Devices › Barrier, absorbable, adhesion
Device brand name · Mcn
Seprafilm: medical device reports filed with FDA
247 reports name it, 2005–2026. Manufacturer given most often on reports: Baxter Healthcare. Product code MCN.
- 247
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 18
- reports, 12 months to August 2026
- 9 in the 12 months before
- 3.2%
- classified as malfunction
- 4% across the product code
- 2.4%
- classified as death, as reported
- 6 reports · not verified by FDA
247 medical device reports received by FDA name the brand "Seprafilm" (mcn); the manufacturer given most often on reports is Baxter Healthcare; received from January 2005 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
18 reports arrived in the 12 months to August 2026, up 100% from 9 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 (92.7%), malfunction (3.2%) and death (2.4%); across all barrier, absorbable, adhesion reports (product code MCN) death is recorded in 1.9% and malfunction in 4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device remains implanted (12.1%), patient-device incompatibility (5.7%) and defective device (3.2%). The patient problems coded most often are abscess, adhesion(s) 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
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 1,562 reports carrying product code MCN. 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 |
|---|---|---|---|
| Device remains implanted | 30 | 12.1% | 5.1% |
| Patient-device incompatibilitythe device did not suit the patient | 14 | 5.7% | 2.3% |
| Defective devicethe device was defective | 8 | 3.2% | 0.6% |
| Improper or incorrect procedure or method | 7 | 2.8% | 1.2% |
| Device contamination with chemical or other material | 4 | 1.6% | 0.4% |
| Device issuea problem with the device | 3 | 1.2% | 0.8% |
| Unexpected therapeutic results | 3 | 1.2% | 0.3% |
| Device, or device fragments remain in patient | 2 | 0.8% | 0.1% |
| Device, removal of (non-implant) | 2 | 0.8% | 0.7% |
| Insufficient device problem information | 2 | 0.8% | 14.2% |
| Leak/splashthe device leaked | 2 | 0.8% | 0.7% |
| Bubble(s) | 1 | 0.4% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.4% | 0.1% |
| Fluid/blood leak | 1 | 0.4% | 0.4% |
| Implant extrusion | 1 | 0.4% | 0.1% |
| Loss of or failure to bond | 1 | 0.4% | 0.1% |
| Malposition of device | 1 | 0.4% | 0.1% |
| Material deformation | 1 | 0.4% | 0.1% |
| Material disintegration | 1 | 0.4% | 0.1% |
| Material rupture | 1 | 0.4% | 0.1% |
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 |
|---|---|---|
| Abscessa collection of pus | 43 | 17.4% |
| Adhesion(s) | 32 | 13% |
| Fever | 31 | 12.6% |
| Inflammationinflammation | 25 | 10.1% |
| Peritonitis | 24 | 9.7% |
| Other (for use when an appropriate patient code cannot be identified) | 22 | 8.9% |
| Abdominal painstomach or belly pain | 20 | 8.1% |
| Hospitalization required | 20 | 8.1% |
| Obstruction/occlusion | 18 | 7.3% |
| Bacterial infectiona bacterial infection | 13 | 5.3% |
| Painpain, site not specified | 13 | 5.3% |
| Therapy/non-surgical treatment, additional | 13 | 5.3% |
| Treatment with medication(s) | 12 | 4.9% |
| Vomitingbeing sick | 10 | 4% |
| Ascitesfluid in the abdomen | 9 | 3.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Seprafilm | Product code MCN | All MAUDE reports |
|---|---|---|---|
| Reports | 247 | 1,562 | 26,136,888 |
| Share of that pool | — | 15.8% | 0% |
| Classified as death, per 1,000 reports | 24 | 19 | 9 |
| Classified as injury | 92.7% | 80.1% | 36.2% |
| Classified as malfunction | 3.2% | 4% | 62.3% |
| Filed by the manufacturer | 96.4% | 95.5% | 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 MCN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Seprafilm Sodium Hyaluronate Carboxymethylcellulose Membrane | 213 | 0 | 0.9% |
| Gynecare Intergel | 181 | 0 | 3.3% |
| Interceed Tc7 Absorbable Adhesion Barrier | 189 | 0 | 0% |
| SepraMesh IP | 1,891 | 43 | 0.8% |
| MED-EL Combi 40+ Cochlear Implant System | 6,149 | 0 | 0% |
| Gynecare TVT | 679 | 3 | 0% |
| Nucleus CI512 Cochlear Implant with Contour Advance Electrode | 2,605 | 232 | 0% |
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 Seprafilm reports
How many FDA reports name Seprafilm?
247 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 18 in the latest 12 months.
What kinds of events are reported?
injury (92.7%), malfunction (3.2%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device remains implanted (12.1%), patient-device incompatibility (5.7%), defective device (3.2%), improper or incorrect procedure or method (2.8%) and device contamination with chemical or other material (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.4%) and voluntary reports (3.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Seprafilm 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.