MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-10-05 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical Inc..
[17513650]
In 2001 the vp of sales at gliatech had a conversation with one of the area mgrs of distributors for the co. The area mgr had a conversation with a dr at the october naas meeting. The following info is from the area mgrs recollection: type of surgery-"micordiscectomy/lumbar"; date of surgery-" mid 2000??. Don't know the exact date of surgery"; pt presented - "epidural hematoma"; action taken-" re-op. Pt resolved. No problems. The dr said the only thing different was that adcon-l device used. Stated he doesn't know if adcon-l was to blame. He was aware of negative publicity at the time, so this could be perception more than reality. " repeated attempts were made to reach the dr involved, who would not respond to any inquiries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00311 |
| MDR Report Key | 354752 |
| Report Source | 05 |
| Date Received | 2001-10-05 |
| Date of Report | 2001-10-05 |
| Date Mfgr Received | 2001-09-06 |
| Date Added to Maude | 2001-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 23420 COMMERCE PARK ROAD |
| Manufacturer City | CLEVELAND OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168313200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADCON-L ANTI-ADHESION BARRIER GEL |
| Generic Name | INHIBITOR, PERIDURAL |
| Product Code | MLQ |
| Date Received | 2001-10-05 |
| Model Number | NA |
| Catalog Number | G0001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 343972 |
| Manufacturer | GLIATECH MEDICAL INC. |
| Manufacturer Address | 23420 COMMERCE PARK ROAD CLEVELAND OH 44122 US |
| Baseline Brand Name | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Generic Name | INHIBITOR, PERIDURAL FIBROSIS |
| Baseline Model No | NA |
| Baseline Catalog No | G0001 |
| Baseline ID | NA |
| Baseline Device Family | ADCON-L ADHESION CONTROL IN A BARRIER GEL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-05 |