Devices › Agent, absorbable hemostatic, collagen based
Device brand name · Agent absorbable hemostatic collagen based
Floseal Hemostatic Matrix: medical device reports filed with FDA
233 reports name it, 2008–2025. Manufacturer given most often on reports: Baxter Healthcare - Hayward. Product code LMF.
- 233
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 1
- reports, 12 months to August 2026
- 5 in the 12 months before
- 17.6%
- classified as malfunction
- 14.7% across the product code
- 6.9%
- classified as death, as reported
- 16 reports · not verified by FDA
FDA's MAUDE database holds 233 reports that name the brand "Floseal Hemostatic Matrix" (agent absorbable hemostatic collagen based), received between March 2008 and November 2025; the manufacturer given most often on reports is Baxter Healthcare - Hayward. Spellings of one product vary from report to report.
1 reports arrived in the 12 months to August 2026, down 80% from 5 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 (74.7%), malfunction (17.6%) and death (6.9%); across all agent, absorbable hemostatic, collagen based reports (product code LMF) death is recorded in 4.4% and malfunction in 14.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (38.2%), device operates differently than expected (10.3%) and improper or incorrect procedure or method (10.3%). The patient problems coded most often are adhesion(s), hemorrhage/blood loss/bleeding and death. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,114 reports carrying product code LMF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 89 | 38.2% | 9.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 24 | 10.3% | 3.1% |
| Improper or incorrect procedure or method | 24 | 10.3% | 11% |
| Device contamination with chemical or other material | 15 | 6.4% | 4.5% |
| Patient-device incompatibilitythe device did not suit the patient | 15 | 6.4% | 3.2% |
| Migration or expulsion of device | 5 | 2.1% | 0.8% |
| Shelf life exceeded | 4 | 1.7% | 0.1% |
| Sticking | 3 | 1.3% | 0% |
| Contamination of device ingredient or reagent | 2 | 0.9% | 0.1% |
| Explanted | 2 | 0.9% | 0.7% |
| Method, improper/incorrect | 2 | 0.9% | 0.1% |
| Crackthe device cracked | 1 | 0.4% | 0.4% |
| Device expiration issue | 1 | 0.4% | 0.1% |
| Device issuea problem with the device | 1 | 0.4% | 0.5% |
| Device packaging compromised | 1 | 0.4% | 0% |
| Device, removal of (non-implant) | 1 | 0.4% | 0.3% |
| Device-device incompatibility | 1 | 0.4% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.4% | 0% |
| Fluid/blood leak | 1 | 0.4% | 0.1% |
| Foreign material | 1 | 0.4% | 0.8% |
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) | Reports | Share |
|---|---|---|
| Adhesion(s) | 25 | 10.7% |
| Hemorrhage/blood loss/bleeding | 25 | 10.7% |
| Deaththe patient died; cause not stated by this term | 15 | 6.4% |
| Painpain, site not specified | 14 | 6% |
| Abdominal painstomach or belly pain | 13 | 5.6% |
| Fever | 13 | 5.6% |
| Inflammationinflammation | 12 | 5.2% |
| Post operative wound infection | 12 | 5.2% |
| Therapy/non-surgical treatment, additional | 12 | 5.2% |
| Abscessa collection of pus | 11 | 4.7% |
| Nauseafeeling sick | 9 | 3.9% |
| Pulmonary embolisma blood clot in the lung | 9 | 3.9% |
| Calcium deposits/calcification | 7 | 3% |
| Obstruction/occlusion | 7 | 3% |
| Purulent discharge | 7 | 3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Floseal Hemostatic Matrix | Product code LMF | All MAUDE reports |
|---|---|---|---|
| Reports | 233 | 2,114 | 26,136,888 |
| Share of that pool | — | 11% | 0% |
| Classified as death, per 1,000 reports | 69 | 44 | 9 |
| Classified as injury | 74.7% | 79.5% | 36.2% |
| Classified as malfunction | 17.6% | 14.7% | 62.3% |
| Filed by the manufacturer | 96.1% | 91.5% | 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 LMF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gelfoam | 416 | 9 | 7.7% |
| Floseal | 270 | 7 | 3.7% |
| Surgicel Absorbable Hemostat | 289 | 0 | 2.1% |
| Surgicel Absorbable Hemostat Unknown | 334 | 26 | 3.3% |
| Vasoseal Vhd | 639 | 0 | 1.3% |
| Baxter | 821 | 3 | 3.8% |
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 Floseal Hemostatic Matrix reports
How many FDA reports name Floseal Hemostatic Matrix?
233 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (74.7%), malfunction (17.6%) and death (6.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (38.2%), device operates differently than expected (10.3%), improper or incorrect procedure or method (10.3%), device contamination with chemical or other material (6.4%) and patient-device incompatibility (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.1%) and voluntary reports (1.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Floseal Hemostatic Matrix 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.