Reported Reactions

Devices › Agent, absorbable hemostatic, non-collagen based

Device brand name · Agent absorbable hemostatic non-collagen based

Surgicel Powder Usa - Absorbable Hemostatic Pwdr: medical device reports filed with FDA

293 reports name it, 2019–2025. Manufacturer given most often on reports: Ethicon. Product code LMG.

293
device reports naming the brand
0% of all MAUDE reports · about 42 a year
0
reports, 12 months to August 2026
37 in the 12 months before
2.7%
classified as malfunction
23% across the product code
0.3%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 293 reports that name the brand "Surgicel Powder Usa - Absorbable Hemostatic Pwdr" (agent absorbable hemostatic non-collagen based), received between August 2019 and March 2025; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 37 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 (96.9%), malfunction (2.7%) and death (0.3%); across all agent, absorbable hemostatic, non-collagen based reports (product code LMG) death is recorded in 1.5% and malfunction in 23%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material integrity problem (1%), device contaminated during manufacture or shipping (0.7%) and contamination /decontamination problem (0.3%). The patient problems coded most often are abscess, not applicable and fever. 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."

Reports by month, five years

0713Sep 2021: 1Oct 2021: 8Nov 2021: 4Dec 2021: 02022Jan 2022: 4Feb 2022: 2Mar 2022: 11Apr 2022: 3May 2022: 1Jun 2022: 4Jul 2022: 4Aug 2022: 1Sep 2022: 2Oct 2022: 6Nov 2022: 3Dec 2022: 12023Jan 2023: 6Feb 2023: 4Mar 2023: 2Apr 2023: 5May 2023: 13Jun 2023: 3Jul 2023: 3Aug 2023: 8Sep 2023: 1Oct 2023: 0Nov 2023: 3Dec 2023: 42024Jan 2024: 0Feb 2024: 2Mar 2024: 1Apr 2024: 0May 2024: 0Jun 2024: 4Jul 2024: 1Aug 2024: 3Sep 2024: 4Oct 2024: 3Nov 2024: 7Dec 2024: 102025Jan 2025: 10Feb 2025: 0Mar 2025: 3Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

By year received

043862019: 1020192020: 8620202021: 5520212022: 4220222023: 5220232024: 3520242025: 132025

Event type and report source

Event type, as classified on the report

Death0.3%1
Injury96.9%284
Malfunction2.7%8
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%293
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,764 reports carrying product code LMG. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Material integrity problema problem with the device material31%1.6%
Device contaminated during manufacture or shipping20.7%4%
Contamination /decontamination problem10.3%0.2%
Delivered as unsterile product10.3%5.2%
Unsealed device packaging10.3%0.2%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Abscessa collection of pus4515.4%
Not applicable3712.6%
Fever289.6%
Painpain, site not specified217.2%
Hematomaa collection of blood under the skin or in tissue175.8%
Seromaa collection of fluid under the skin155.1%
Paralysis124.1%
Failure to anastomose113.8%
Hemorrhage/blood loss/bleeding113.8%
Inflammationinflammation113.8%
Appropriate clinical signs, symptoms and conditions term/code not available103.4%
Foreign body in patientpart of a device left in the patient103.4%
Nerve damage93.1%
Wound dehiscencea wound reopened72.4%
Adhesion(s)62%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureSurgicel Powder Usa - Absorbable Hemostatic PwdrProduct code LMGAll MAUDE reports
Reports2931,76426,136,888
Share of that pool—16.6%0%
Classified as death, per 1,000 reports3159
Classified as injury96.9%74.9%36.2%
Classified as malfunction2.7%23%62.3%
Filed by the manufacturer100%97.3%94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code LMG

BrandReportsLatest 12 monthsClassified as death
Surgicel Absorbable Hemostat Unknown334263.3%
Surgicel Absorbable Hemostat28902.1%
Ethicon1,1001642.3%
Floseal27073.7%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Surgicel Powder Usa - Absorbable Hemostatic Pwdr reports

How many FDA reports name Surgicel Powder Usa - Absorbable Hemostatic Pwdr?

293 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (96.9%), malfunction (2.7%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material integrity problem (1%), device contaminated during manufacture or shipping (0.7%), contamination /decontamination problem (0.3%), delivered as unsterile product (0.3%) and unsealed device packaging (0.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Surgicel Powder Usa - Absorbable Hemostatic Pwdr was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.