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..
[232517]
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 adverse events in five pts in whom adcon-l had been administered. Each pt developed a post-operative deep wound infection. The clinical contact for the dr later indicated that it was "between five and eight" pts that had developed deep wound infection. She then stated that they had not observed other infections during the same time period and that she felt "pretty sure" they had "narrowed it down to one product [adcon-l]". Subsequent conversation with the clinical contact revealed that the events had occurred atleast 3 months prior to the recall of adcon-l (january 2001). Patient 1 - deep wound infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2001-00302 |
| MDR Report Key | 353792 |
| 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 | 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 | 343010 |
| 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. Other | 2001-09-27 |