Agent, absorbable hemostatic, non-collagen based: medical device reports filed with FDA

1,764 reports carry this product code, 1996–2026; 5 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.

1,764
reports with this product code: 0% of all MAUDE reports; 228
reports, 12 months to August 2026: 239 in the 12 months before; 23%
classified as malfunction: 62.3% across all reports; 1.5%
classified as death, as reported: 0.9% across all reports

Product code LMG is FDA's classification for "Agent, absorbable hemostatic, non-collagen based" (general, Plastic Surgery panel), a class 3 device. 1,764 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

228 reports arrived in the 12 months to August 2026, close to the 239 of 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 (74.9%), malfunction (23%) and death (1.5%). 5 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
Surgicel Absorbable Hemostat Unknown	296	26	3.3%	3%
Surgicel Powder Usa - Absorbable Hemostatic Pwdr	293	0	0.3%	2.7%
Surgicel Absorbable Hemostat	122	0	2.1%	0.7%
Ethicon	1	164	2.3%	54.2%
Floseal	1	7	3.7%	35.2%

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
Ethicon	307	17.4%
Davol Sub C R Bard -1213643	89	5%
Covidien North Haven	51	2.9%
Davol Sub C R Bard	44	2.5%
Covidien Surgical	4	0.2%
Cryolife	3	0.2%

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

Death1.5%27

Injury74.9%1,321

Malfunction23%406

Other0.5%9

Not given0.1%1

Who filed

Manufacturer report97.3%1,716

Voluntary report1.8%32

User facility report0%0

Distributor report0.6%10

Not given0.3%6

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device markings/labelling problema problem with the device markings or label	100	5.7%
Delivered as unsterile product	91	5.2%
Patient-device incompatibilitythe device did not suit the patient	73	4.1%
Device contaminated during manufacture or shipping	70	4%
Reactiona reaction, type not specified	68	3.9%
Other (for use when an appropriate device code cannot be identified)	41	2.3%
Insufficient device problem information	28	1.6%
Material integrity problema problem with the device material	28	1.6%
Patient device interaction problem	28	1.6%
Breakthe device broke	18	1%
Degraded	13	0.7%
Product quality problem	11	0.6%
Component missing	10	0.6%
Packaging problem	10	0.6%
Explanted	9	0.5%
Migration or expulsion of device	7	0.4%
Detachment of device or device componentpart of the device came off	6	0.3%
Device contamination with chemical or other material	6	0.3%
Device remains implanted	6	0.3%
Loss of or failure to bond	6	0.3%

Questions about agent, absorbable hemostatic, non-collagen based reports

What is product code LMG?

FDA's classification code for "Agent, absorbable hemostatic, non-collagen based", class 3, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,764 reports through August 2026, 228 of them in the latest 12 months.

Which brands appear most often?

Surgicel Absorbable Hemostat Unknown (296), Surgicel Powder Usa - Absorbable Hemostatic Pwdr (293), Surgicel Absorbable Hemostat (122), Ethicon (1) and Floseal (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.