MedDRA preferred term · a physical defect in the product

Product physical issue: adverse event reports recording this term

19,670 reports to FDA record it, 2009–2026; 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.

19,670
reports recording the term: 0.1% of all reports; 1,655
reports, 12 months to June 2026: 1,582 in the 12 months before; 18.2%
marked serious by the reporter: 57.4% across all reports; 0.5%
record death among outcomes, as reported: 9.1% across all reports

"Product physical issue" (in plain words, a physical defect in the product) is a MedDRA preferred term recorded in 19,670 adverse event reports received by FDA, 0.1% of the database, from August 2009 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,655 reports recorded it in the 12 months to June 2026, close to the 1,582 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, 18.2% are marked serious, 0.5% include death among the outcomes and 4.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Sumatriptan Injection Usp 6 Mg/0 5 Ml, Vascepa and Tiotropium bromide. 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
Sumatriptan Injection Usp 6 Mg/0 5 Ml	—	2,093	78.2%
Vascepa	—	857	20.8%
Tiotropium bromide	Anticholinergic	702	0.9%
Vyvanse	Central nervous system stimulant	607	3.5%
Climara Pro	Estrogen	329	16.9%
Advil	Nonsteroidal anti-inflammatory drug	240	1.2%
Opzelura	Janus kinase inhibitor	215	6.5%
Adderall	Central nervous system stimulant	212	2.1%
Ninlaro	Proteasome inhibitor	211	1.9%
Zecuity	—	199	6.9%
Xtandi	Androgen receptor inhibitor	168	0.4%
Aleve	Nonsteroidal anti-inflammatory drug	151	0.3%
Novorapid	—	151	2.2%
Revlimid	Thalidomide analog	149	0%
Estradiol	Estrogen	145	0.9%
Synthroid	l-Thyroxine	144	0.5%
ProAir RespiClick	beta2-Adrenergic agonist	135	8.4%
Linzess	Guanylate Cyclase-C agonist	129	0.9%
Butrans	Partial opioid agonist	126	0.2%
Inbrija	Aromatic amino acid	125	2.1%
MiraLAX	Osmotic laxative	123	0.3%
Genotropin	—	115	0.3%
Spiriva Handihaler	—	109	14%
Imodium Multi-Symptom Relief	—	104	1.9%
Risperdal Consta	—	103	0.8%

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
Central nervous system stimulant	1,076	1%	0.1%
Anticholinergic	735	0.5%	0%
Estrogen	708	0.6%	0%
Nonsteroidal anti-inflammatory drug	616	0.1%	0%
Opioid agonist	399	0%	0%
Janus kinase inhibitor	334	0.1%	0%
Benzodiazepine	306	0.1%	0.1%
Proteasome inhibitor	300	0.3%	0%
Androgen receptor inhibitor	272	0.4%	0.2%
Kinase inhibitor	260	0%	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 20.1%28

2 to 111.6%305

12 to 171%203

18 to 448.5%1,672

45 to 6415.7%3,094

65 to 7410%1,969

75 and over7.5%1,479

Age not given55.5%10,920

Patient sex

Female56.2%11,047

Male28.8%5,669

Not given15%2,954

Grey bar: all 20,646,523 reports in the database. 92% of these reports give the United States as the country.

Questions about "Product physical issue"

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

In plain language: a physical defect in the product. 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 product physical issue?

19,670 reports through June 2026 (0.1% of all reports), 1,655 of them in the latest 12 months.

Which drugs appear most often in these reports?

Sumatriptan Injection Usp 6 Mg/0 5 Ml (2,093), Vascepa (857), Tiotropium bromide (702), Vyvanse (607) and Climara Pro (329). 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.