MedDRA preferred term

Device mechanical issue: adverse event reports recording this term

12,736 reports to FDA record it, 2017–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

12,736
reports recording the term: 0.1% of all reports; 3,188
reports, 12 months to June 2026: 3,382 in the 12 months before; 5%
marked serious by the reporter: 57.4% across all reports; 0.1%
record death among outcomes, as reported: 9.1% across all reports

12,736 reports in FDA's adverse event database record the MedDRA term "Device mechanical issue": 0.1% of all reports received between May 2017 and June 2026. Coders pick the term that best matches the reporter's description.

3,188 reports recorded it in the 12 months to June 2026, close to the 3,382 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 5% are marked serious, 0.1% include death among the outcomes and 1.4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Genotropin, Semglee and Omnitrope. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Genotropin	—	7,109	15.8%
Semglee	Insulin analog	913	45%
Omnitrope	Recombinant human growth hormone	437	3.9%
Albuterol	beta2-Adrenergic agonist	424	2.4%
Lantus Solostar	Insulin analog	360	0.8%
Insulin glargine	Insulin analog	306	1.1%
Device	—	236	4.7%
Albuterol sulfate	beta2-Adrenergic agonist	222	0.5%
Enbrel	Tumor necrosis factor blocker	187	0%
Lantus	Insulin analog	166	0.4%
Wixela Inhub	Corticosteroid	158	7.9%
Somatropin	Recombinant human growth hormone	140	2.5%
Glatopa	—	131	2.2%
ParaGard T 380A	Copper-containing intrauterine device	120	0.3%
Abrilada	—	117	4.9%
Tiotropium bromide	Anticholinergic	103	0.1%
Simponi	Tumor necrosis factor blocker	93	0.1%
Bydureon Bcise	—	86	0.7%
Toujeo	Insulin analog	83	0.5%
Depo-Provera	Progestin	78	0.4%
Cosentyx	Interleukin-17A antagonist	66	0%
Neulasta	Leukocyte growth factor	64	0.1%
Guselkumab	Interleukin-23 antagonist	58	2.8%
Ozempic	GLP-1 receptor agonist	57	0.1%
Rasuvo	Folate analog metabolic inhibitor	57	1.9%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Insulin analog	1,908	0.7%	0%
beta2-Adrenergic agonist	648	0.7%	0%
Recombinant human growth hormone	617	2.9%	2.5%
Tumor necrosis factor blocker	368	0%	0%
Corticosteroid	253	0%	0%
GLP-1 receptor agonist	165	0%	0%
Progestin	123	0%	0%
Copper-containing intrauterine device	120	0.3%	0.2%
Anticholinergic	116	0.1%	0%
Interleukin-23 antagonist	102	0.1%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.5%67

2 to 1119.2%2,444

12 to 1725.9%3,297

18 to 445.3%679

45 to 647.4%942

65 to 744.8%615

75 and over3.9%502

Age not given32.9%4,190

Patient sex

Female37.9%4,830

Male45.3%5,771

Not given16.8%2,135

Grey bar: all 20,646,523 reports in the database. 70.8% of these reports give the United States as the country.

Questions about "Device mechanical issue"

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

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record device mechanical issue?

12,736 reports through June 2026 (0.1% of all reports), 3,188 of them in the latest 12 months.

Which drugs appear most often in these reports?

Genotropin (7,109), Semglee (913), Omnitrope (437), Albuterol (424) and Lantus Solostar (360). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.