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

2,114 reports carry this product code, 1996–2026; 7 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.

2,114
reports with this product code: 0% of all MAUDE reports; 92
reports, 12 months to August 2026: 95 in the 12 months before; 14.7%
classified as malfunction: 62.3% across all reports; 4.4%
classified as death, as reported: 0.9% across all reports

Product code LMF is FDA's classification for "Agent, absorbable hemostatic, collagen based" (general, Plastic Surgery panel), a class 3 device. 2,114 medical device reports carry this product code, 0% of the MAUDE database, from May 1996 to August 2026.

92 reports arrived in the 12 months to August 2026, close to the 95 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 (79.5%), malfunction (14.7%) and death (4.4%). 7 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
Gelfoam	415	9	7.7%	7%
Floseal	264	7	3.7%	35.2%
Floseal Hemostatic Matrix	223	1	6.9%	17.6%
Surgicel Absorbable Hemostat	166	0	2.1%	0.7%
Surgicel Absorbable Hemostat Unknown	38	26	3.3%	3%
Vasoseal Vhd	2	0	1.3%	21%
Baxter	1	3	3.8%	54.2%

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
Baxter Healthcare	38	1.8%
Davol Sub C R Bard -1213643	22	1%
Davol Sub C R Bard	21	1%
Integra Neurosciences Pr	16	0.8%
Davol	8	0.4%
Ethicon Sarl	6	0.3%
Stryker Instruments	5	0.2%
Integra Lifesciences	3	0.1%
Baxter Healthcare - Irvine	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

Death4.4%92

Injury79.5%1,681

Malfunction14.7%311

Other0.7%14

Not given0.8%16

Who filed

Manufacturer report91.5%1,934

Voluntary report3.2%68

User facility report0%0

Distributor report3.2%68

Not given2.1%44

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

Device problems coded

Device problem (FDA code)	Reports	Share
Off-label use	281	13.3%
Improper or incorrect procedure or method	232	11%
Insufficient device problem information	208	9.8%
Other (for use when an appropriate device code cannot be identified)	120	5.7%
Device contamination with chemical or other material	95	4.5%
Patient-device incompatibilitythe device did not suit the patient	68	3.2%
Device operates differently than expectedthe device behaved unexpectedly	65	3.1%
Lack of effect	46	2.2%
Reactiona reaction, type not specified	37	1.8%
Defective devicethe device was defective	29	1.4%
Patient device interaction problem	27	1.3%
Foreign material	16	0.8%
Migration or expulsion of device	16	0.8%
Breakthe device broke	15	0.7%
Explanted	14	0.7%
Device appears to trigger rejection	13	0.6%
Product quality problem	13	0.6%
Therapeutic or diagnostic output failure	12	0.6%
Device handling problem	11	0.5%
Device issuea problem with the device	10	0.5%

Questions about agent, absorbable hemostatic, collagen based reports

What is product code LMF?

FDA's classification code for "Agent, absorbable hemostatic, 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?

2,114 reports through August 2026, 92 of them in the latest 12 months.

Which brands appear most often?

Gelfoam (415), Floseal (264), Floseal Hemostatic Matrix (223), Surgicel Absorbable Hemostat (166) and Surgicel Absorbable Hemostat Unknown (38). 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.