Device brand name · Absorbable adhesion barrier

Gynecare Intergel: medical device reports filed with FDA

181 reports name it, 2002–2006. Manufacturer given most often on reports: Lifecore Biomedical. Product code MCN.

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.

181
device reports naming the brand: 0% of all MAUDE reports · about 7 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 2.2%
classified as malfunction: 4% across the product code; 3.3%
classified as death, as reported: 6 reports · not verified by FDA

181 medical device reports received by FDA name the brand "Gynecare Intergel" (absorbable adhesion barrier); the manufacturer given most often on reports is Lifecore Biomedical; received from February 2002 to November 2006. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (79.6%), other (14.9%) and death (3.3%); 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 reaction (18.8%), device, removal of (non-implant) (4.4%) and fluid/blood leak (2.2%). The patient problems coded most often are pain, therapy/non-surgical treatment, additional and swelling. 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

No report naming Gynecare Intergel was received in the five years to August 2026; the latest was received in November 2006.

By year received

Event type and report source

Event type, as classified on the report

Death3.3%6

Injury79.6%144

Malfunction2.2%4

Other14.9%27

Not given0%0

Who filed the report

Manufacturer report95%172

Voluntary report3.3%6

User facility report0%0

Distributor report0%0

Not given1.7%3

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
Reactiona reaction, type not specified	34	18.8%	5.7%
Device, removal of (non-implant)	8	4.4%	0.7%
Fluid/blood leak	4	2.2%	0.4%
Leak/splashthe device leaked	4	2.2%	0.7%
Migration or expulsion of device	3	1.7%	2%
Other (for use when an appropriate device code cannot be identified)	3	1.7%	4.7%
Explanted	2	1.1%	1.1%
Device remains implanted	1	0.6%	5.1%
Difficult to insertthe device was hard to insert	1	0.6%	0%
Foreign material	1	0.6%	0.1%
Kinkedthe tube or line kinked	1	0.6%	0%

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
Painpain, site not specified	93	51.4%
Therapy/non-surgical treatment, additional	56	30.9%
Swellingswelling	54	29.8%
Hospitalization required	52	28.7%
Surgical procedure	51	28.2%
Abdominal painstomach or belly pain	50	27.6%
Injurya physical injury	44	24.3%
Fever	41	22.7%
Treatment with medication(s)	39	21.5%
Other (for use when an appropriate patient code cannot be identified)	34	18.8%
Peritonitis	27	14.9%
Adhesion(s)	17	9.4%
Inflammationinflammation	17	9.4%
Obstruction/occlusion	16	8.8%
Scarring	14	7.7%

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

In context

Measure	Gynecare Intergel	Product code MCN	All MAUDE reports
Reports	181	1,562	26,136,888
Share of that pool	—	11.6%	0%
Classified as death, per 1,000 reports	33	19	9
Classified as injury	79.6%	80.1%	36.2%
Classified as malfunction	2.2%	4%	62.3%
Filed by the manufacturer	95%	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	247	18	2.4%
Seprafilm Sodium Hyaluronate Carboxymethylcellulose Membrane	213	0	0.9%
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 Gynecare Intergel reports

How many FDA reports name Gynecare Intergel?

181 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 (79.6%), other (14.9%) and death (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

reaction (18.8%), device, removal of (non-implant) (4.4%), fluid/blood leak (2.2%), leak/splash (2.2%) and migration or expulsion of device (1.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (95%) and voluntary reports (3.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Gynecare Intergel 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.