MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-05-03 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..
[16145777]
On 04/2002, a gliatech employee received a "notice of product liability claims" from attorney. The letter states that, "the claims related to batches of adcon-l which were the subject of a product recall. The co's clients all underwent disc surgeries in the fall of 2000. All three individuals were treated with batches of adcon-l which were subsequently recalled. As you know, the recall was prompted by findings that packages containing adcon-l were contaminated, at a minimum, with aluminum shavings. All three individuals developed serious infections shortly after administration of adcon-l. It is the co's belief that the co's clients' infections were caused by contaminated adcon-l and they are entitled to compensation. " no additional information is currently available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00013 |
| MDR Report Key | 392071 |
| Report Source | 00 |
| Date Received | 2002-05-03 |
| Date of Report | 2002-05-03 |
| Date Mfgr Received | 2002-04-22 |
| Date Added to Maude | 2002-05-08 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 2002-05-03 |
| 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 | 381100 |
| 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 | 2002-05-03 |