Devices › Inhibitor, peridural fibrosis (adhesion barrier)
Device brand name · Inhibitor peridural
Adcon-L Anti-Adhesion Barrier Gel: medical device reports filed with FDA
318 reports name it, 2000–2002. Manufacturer given most often on reports: Gliatech Medical. Product code MLQ.
- 318
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.3%
- classified as malfunction
- 1.1% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 318 reports that name the brand "Adcon-L Anti-Adhesion Barrier Gel" (inhibitor peridural), received between July 2000 and November 2002; the manufacturer given most often on reports is Gliatech Medical. Spellings of one product vary from report to report.
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 (98.4%), malfunction (1.3%) and death (0.3%); across all inhibitor, peridural fibrosis (adhesion barrier) reports (product code MLQ) death is recorded in 0.5% and malfunction in 1.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device remains implanted (64.2%), reaction (8.5%) and repair (1.6%). The patient problems coded most often are therapy/non-surgical treatment, additional, pain and treatment with medication(s). 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 Adcon-L Anti-Adhesion Barrier Gel was received in the five years to August 2026; the latest was received in November 2002.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 440 reports carrying product code MLQ. 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 | 204 | 64.2% | 48.4% |
| Reactiona reaction, type not specified | 27 | 8.5% | 10.5% |
| Repair | 5 | 1.6% | 1.1% |
| Contamination | 2 | 0.6% | 0.7% |
| Material separation | 2 | 0.6% | 0.5% |
| Delivered as unsterile product | 1 | 0.3% | 0.2% |
| Device, removal of (non-implant) | 1 | 0.3% | 0.9% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0.2% |
| Fluid/blood leak | 1 | 0.3% | 0.2% |
| Leak/splashthe device leaked | 1 | 0.3% | 0.5% |
| Loss of or failure to bond | 1 | 0.3% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 1 | 0.3% | 4.5% |
| Out-of-box failure | 1 | 0.3% | 0.2% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 163 | 51.3% |
| Painpain, site not specified | 160 | 50.3% |
| Treatment with medication(s) | 150 | 47.2% |
| Other (for use when an appropriate patient code cannot be identified) | 49 | 15.4% |
| Surgical procedure | 28 | 8.8% |
| Hospitalization required | 27 | 8.5% |
| Inflammationinflammation | 27 | 8.5% |
| Rupturethe device burst | 27 | 8.5% |
| Hernia | 21 | 6.6% |
| Muscle spasm(s) | 20 | 6.3% |
| Spinal column injury | 13 | 4.1% |
| Surgical procedure, repeated | 13 | 4.1% |
| Low blood pressure/ hypotension | 12 | 3.8% |
| Post operative wound infection | 11 | 3.5% |
| Swellingswelling | 11 | 3.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Adcon-L Anti-Adhesion Barrier Gel | Product code MLQ | All MAUDE reports |
|---|---|---|---|
| Reports | 318 | 440 | 26,136,888 |
| Share of that pool | — | 72.3% | 0% |
| Classified as death, per 1,000 reports | 3 | 5 | 9 |
| Classified as injury | 98.4% | 95.5% | 36.2% |
| Classified as malfunction | 1.3% | 1.1% | 62.3% |
| Filed by the manufacturer | 100% | 95.9% | 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."
Questions about Adcon-L Anti-Adhesion Barrier Gel reports
How many FDA reports name Adcon-L Anti-Adhesion Barrier Gel?
318 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 (98.4%), malfunction (1.3%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device remains implanted (64.2%), reaction (8.5%), repair (1.6%), contamination (0.6%) and material separation (0.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Adcon-L Anti-Adhesion Barrier Gel 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.