MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-05-03 for ADCON-L ANTI-ADHESION BARRIER GEL G0001 manufactured by Gliatech Medical, Inc..
[21707429]
In april 2002, a gliatech employee received a report through the fda medwatch medicinal products reporting program. The reporter wished to remain anonymous to the manufacturer. Many portions of the report were redacted. The following is what remains on the form: "pt had mld rt l4-5 [redacted]. Returned to or on [redacted] due to mass (epidural) at rt l4-5. Tissue removed was sent for frozen section and permanent (sic). Surgery on [redacted] used adcon-l. Frozen section report showed reactive changes. Questions arose concerning use of adcon-l. " no additional information is currently available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00012 |
| MDR Report Key | 392079 |
| Report Source | 05 |
| Date Received | 2002-05-03 |
| Date of Report | 2002-05-03 |
| Date Mfgr Received | 2002-04-25 |
| 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 |
| 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 |
| Remedial Action | MA |
| 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 | 381108 |
| 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 |