MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-27 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..
[208994]
On 08/2001 gliatech rec'd a letter from a consultant clinical specialist for sales and marketing. The letter described a visit that she made to a surgeon who reported that he had observed an adverse event for one pt that had received adcon-l. The pt developed a postoperative deep wound infection. Per the clinical specialist "he had a lumbar disc that reherniated at about 6 months". At reoperation, adcon-l was applied and two days postoperatively the pt experienced "extreme pain followed by fever". At reoperation, a massive infection was detected and determined to be pseudomonas. The wound was debrided, flushed completely, and irrigated with antibiotic solution. This procedure resolved the pain, however, the pt never returned to their preconditioned status. The pt was an active tae kwon do expert, dirt bike rider and a formal body builder. Pt had a history of lumbar discectomy and 2 hip replacements prior to the age of 40. Subsequent to their lumbar discectomies pt had another hip replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00310 |
| MDR Report Key | 353674 |
| Report Source | 05 |
| Date Received | 2001-09-27 |
| Date of Report | 2001-09-27 |
| Date Mfgr Received | 2001-08-28 |
| Date Added to Maude | 2001-10-02 |
| 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 | 2001-09-27 |
| Model Number | NA |
| Catalog Number | G0001 |
| Lot Number | A9102N1 |
| 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 | 342890 |
| Manufacturer | GLIATECH MEDICAL, INC. |
| Manufacturer Address | 23420 COMMERCE PARK RD. 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. Other | 2001-09-27 |