MedDRA preferred term · a physical problem with the device

Device physical property issue: adverse event reports recording this term

7,385 reports to FDA record it, 2010–2026; 0% 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.

7,385
reports recording the term: 0% of all reports; 964
reports, 12 months to June 2026: 1,417 in the 12 months before; 18.5%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

7,385 reports in FDA's adverse event database record the MedDRA term "Device physical property issue" (in plain words, a physical problem with the device): 0% of all reports received between November 2010 and June 2026. Coders pick the term that best matches the reporter's description.

964 reports recorded it in the 12 months to June 2026, down 32% from 1,417 in 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, 18.5% are marked serious, 0.6% include death among the outcomes and 6.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Genotropin, Neulasta and Mirena. 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	—	2,793	6.2%
Neulasta	Leukocyte growth factor	1,374	1.7%
Mirena	Progestin	532	0.4%
Remodulin	Prostacycline vasodilator	145	0.3%
Carbidopa levodopa	Aromatic amino acid	131	0.6%
Humira	—	97	0%
Tyvaso	Prostacycline vasodilator	85	0.3%
Duopa	Aromatic amino acid	72	0.8%
Chloraprep	—	68	1.7%
Enbrel	Tumor necrosis factor blocker	61	0%
Omnitrope	Recombinant human growth hormone	61	0.5%
Estradiol	Estrogen	54	0.3%
Repatha	PCSK9 inhibitor	54	0%
Stelara	Interleukin-12 antagonist	54	0.1%
Somatropin	Recombinant human growth hormone	43	0.8%
Lioresal (baclofen)	gamma-Aminobutyric acid-ergic agonist	42	0.4%
Symbicort	Corticosteroid	41	0.1%
Kyleena	Progestin	39	0.5%
Albuterol sulfate	beta2-Adrenergic agonist	34	0.1%
Cosentyx	Interleukin-17A antagonist	31	0%
Duodopa	—	31	0.2%
Baclofen	gamma-Aminobutyric acid-ergic agonist	29	0.1%
Prolia	RANK ligand inhibitor	29	0%
Teriparatide	Parathyroid hormone analog	28	0.5%
Veletri	Prostacycline vasodilator	27	0.3%

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% 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
Leukocyte growth factor	1,405	1.3%	0%
Progestin	635	0.2%	0%
Prostacycline vasodilator	286	0.2%	0.2%
Aromatic amino acid	207	0.4%	0%
Estrogen	159	0.1%	0%
Recombinant human growth hormone	112	0.5%	0.5%
gamma-Aminobutyric acid-ergic agonist	84	0.2%	0.4%
Corticosteroid	78	0%	0%
Tumor necrosis factor blocker	73	0%	0%
beta2-Adrenergic agonist	58	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 20.3%25

2 to 1112.7%936

12 to 1717.1%1,265

18 to 4411.1%820

45 to 6412.9%951

65 to 748.6%633

75 and over5.2%382

Age not given32.1%2,373

Patient sex

Female48.5%3,582

Male36.9%2,727

Not given14.6%1,076

Grey bar: all 20,646,523 reports in the database. 74.2% of these reports give the United States as the country.

Questions about "Device physical property issue"

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

In plain language: a physical problem with the device. 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 physical property issue?

7,385 reports through June 2026 (0% of all reports), 964 of them in the latest 12 months.

Which drugs appear most often in these reports?

Genotropin (2,793), Neulasta (1,374), Mirena (532), Remodulin (145) and Carbidopa levodopa (131). 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.