Dressing, wound, drug: medical device reports filed with FDA

3,166 reports carry this product code, 1992–2026; 6 brands with a page.

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: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

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.

3,166
reports with this product code: 0% of all MAUDE reports; 233
reports, 12 months to August 2026: 202 in the 12 months before; 36.1%
classified as malfunction: 62.3% across all reports; 2%
classified as death, as reported: 0.9% across all reports

Product code FRO is FDA's classification for "Dressing, wound, drug" (unknown panel), a class U device. 3,166 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

233 reports arrived in the 12 months to August 2026, up 15% from 202 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (53.3%), malfunction (36.1%) and other (7.3%). 6 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Aquacel Extra	37	27	0%	88.5%
Equate	15	37	0.3%	24%
Aquacel Foam	11	124	0%	88.1%
Unknown_Fro_Product	2	7	0%	36.5%
Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing	1	0	0%	99.8%
Medline	1	26,184	0.1%	97.9%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Convatec	914	28.9%
Integra Neurosciences Pr	295	9.3%
Smith & Nephew Medical	185	5.8%
3m Health Care	168	5.3%
Integra Lifesciences	102	3.2%
Convatec Dominican Republic	87	2.7%
Smith & Nephew	52	1.6%
B Braun Medical	46	1.5%
3m	41	1.3%
Vascular Solutions	15	0.5%
Abbott Vascular	7	0.2%
Medline Industries	6	0.2%
B Braun Melsungen	3	0.1%
Stryker Leibinger Freiburg	3	0.1%
Baxter Healthcare	2	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2%64

Injury53.3%1,689

Malfunction36.1%1,143

Other7.3%231

Not given1.2%39

Who filed

Manufacturer report82.2%2,601

Voluntary report14.4%456

User facility report0%0

Distributor report0.5%15

Not given3%94

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Delivered as unsterile product	454	14.3%
Insufficient device problem information	350	11.1%
Unsealed device packaging	226	7.1%
Contamination /decontamination problem	194	6.1%
Patient-device incompatibilitythe device did not suit the patient	175	5.5%
Device contamination with chemical or other material	128	4%
Device operates differently than expectedthe device behaved unexpectedly	117	3.7%
Contamination	110	3.5%
Device contaminated during manufacture or shipping	110	3.5%
Difficult to removethe device was hard to remove	81	2.6%
Packaging problem	80	2.5%
Improper or incorrect procedure or method	79	2.5%
Patient device interaction problem	60	1.9%
Dislodged	45	1.4%
Loose	34	1.1%
Other (for use when an appropriate device code cannot be identified)	33	1%
Device damaged prior to usethe device was damaged before use	29	0.9%
Device packaging compromised	29	0.9%
Sticking	29	0.9%
Device, removal of (non-implant)	28	0.9%

Questions about dressing, wound, drug reports

What is product code FRO?

FDA's classification code for "Dressing, wound, drug", class U, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,166 reports through August 2026, 233 of them in the latest 12 months.

Which brands appear most often?

Aquacel Extra (37), Equate (15), Aquacel Foam (11), Unknown_Fro_Product (2) and Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. 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.