Device mechanical issue adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From May 2017 to June 2026, FDA received 12,736 adverse event reports that record the MedDRA preferred term Device mechanical issue. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 3,188 reports in the 12 months to June 2026 and 3,382 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 238 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 3,188 (0.2%) record this term. Reports for patients aged 12 to 17 were 25.9% of the reports that record this term and 1.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 75 drug pages with 5 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Device mechanical issue name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	7
Abrilada		117
Actemra	Interleukin-6 receptor antagonist	23
Actemra ACTPen	Interleukin-6 receptor antagonist	5
Adalimumab	Tumor necrosis factor blocker	36
Admelog	Insulin analog	10
Airsupra	Corticosteroid	5
Ajovy		7
Albuterol	beta2-Adrenergic agonist	424
Albuterol sulfate	beta2-Adrenergic agonist	222
Breyna	Corticosteroid	42
Breztri	Corticosteroid	10
Bydureon		34
Bydureon Bcise		86
Byetta	GLP-1 receptor agonist	11
Cosentyx	Interleukin-17A antagonist	66
Depo-Provera	Progestin	78
Device		236
Dianeal Pd-2 Peritoneal Dialysis Solution with Dextrose		13
Dupixent	Interleukin-4 receptor alpha antagonist	54
Eligard	Gonadotropin releasing hormone receptor agonist	8
Enbrel	Tumor necrosis factor blocker	187
Fiasp	Insulin analog	9
Filgrastim	Leukocyte growth factor	12
Fragmin	Anti-coagulant	36
Fulphila	Leukocyte growth factor	8
Genotropin		7,109
Glatiramer acetate		29
Glatopa		131
Guselkumab	Interleukin-23 antagonist	58
Hulio		12
Hyrimoz	Tumor necrosis factor blocker	52
Insulin degludec and liraglutide	GLP-1 receptor agonist	7
Insulin glargine	Insulin analog	306
Kesimpta	CD20-directed cytolytic antibody	29
Lanreotide acetate	Somatostatin analog	13
Lantus	Insulin analog	166
Lantus Solostar	Insulin analog	360
Levemir	Insulin analog	11
Liraglutide	GLP-1 receptor agonist	30
Medroxyprogesterone	Progestin	37
Neulasta	Leukocyte growth factor	64
Ngenla	Recombinant human growth hormone	36
Nivestym	Leukocyte growth factor	6
Novolog	Insulin analog	15
Novorapid		19
Nutropin Aq		8
Omnitrope	Recombinant human growth hormone	437
Orencia	Selective T cell costimulation modulator	30
Ozempic	GLP-1 receptor agonist	57
ParaGard T 380A	Copper-containing intrauterine device	120
Plegridy	Interferon beta	10
Rasuvo	Folate analog metabolic inhibitor	57
Retacrit	Erythropoiesis-stimulating agent	5
Ryaltris	Corticosteroid	18
Saxenda	GLP-1 receptor agonist	11
Semglee	Insulin analog	913
Simponi	Tumor necrosis factor blocker	93
Skyrizi	Interleukin-23 antagonist	5
Soliqua 100/33	GLP-1 receptor agonist	25
Somatropin	Recombinant human growth hormone	140
Spiriva Respimat	Anticholinergic	5
Stelara	Interleukin-12 antagonist	13
Sumatriptan succinate	Serotonin-1b and Serotonin-1d receptor agonist	17
Symbicort	Corticosteroid	18
Teriparatide	Parathyroid hormone analog	22
Tiotropium bromide	Anticholinergic	103
Toujeo	Insulin analog	83
TOUJEO Max	Insulin analog	20
Tremfya	Interleukin-23 antagonist	39
Tresiba	Insulin analog	15
Tymlos		48
Wegovy	GLP-1 receptor agonist	22
Wixela Inhub	Corticosteroid	158
Xolair	Anti-IgE	10

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 27 pharmacologic classes with 5 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Device mechanical issue name, in order of name
Class	Reports with this term
Anti-coagulant	39
Anti-IgE	10
Anticholinergic	116
beta2-Adrenergic agonist	648
Catecholamine	8
CD20-directed cytolytic antibody	29
Copper-containing intrauterine device	120
Corticosteroid	253
Erythropoiesis-stimulating agent	5
Folate analog metabolic inhibitor	57
GLP-1 receptor agonist	165
Gonadotropin releasing hormone receptor agonist	8
Insulin analog	1,908
Interferon beta	10
Interleukin-12 antagonist	13
Interleukin-17A antagonist	68
Interleukin-23 antagonist	102
Interleukin-4 receptor alpha antagonist	54
Interleukin-6 receptor antagonist	28
Leukocyte growth factor	76
Parathyroid hormone analog	22
Progestin	123
Recombinant human growth hormone	617
Selective T cell costimulation modulator	37
Serotonin-1b and Serotonin-1d receptor agonist	19
Somatostatin analog	13
Tumor necrosis factor blocker	368

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Device mechanical issue, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Device mechanical issue
Age	Reports	Share
Under 2	67	0.5%
2 to 11	2,444	19.2%
12 to 17	3,297	25.9%
18 to 44	679	5.3%
45 to 64	942	7.4%
65 to 74	615	4.8%
75 and over	502	3.9%
Age not given	4,190	32.9%

Sex of the patient in the reports that record Device mechanical issue
Sex	Reports	Share
Female	4,830	37.9%
Male	5,771	45.3%
Unknown or not given	2,135	16.8%

Age and sex are as the report gives them. 70.8% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Device mechanical issue: adverse event reports that record this term. https://reportedreactions.com/reaction/device-mechanical-issue/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Device mechanical issue mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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