MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-11-20 for ADCON-L ANTI-ADHESION BARRIER GEL G0026 manufactured by Gliatech Medical Inc..
[298680]
On 10/21/02, gliatech was made aware that, for one unit of adcon-l, "when opening the package... The outer lid split, thus making it impossible to remove the inner packaging without contamination". The information was received from distributor. The product was not administered to a patient. Product information is: # g0026, lot #01198n1, expiration date june 2003. A return goods authority was provided to the distributor. The product was returned to gliatech 11/11/02.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530649-2002-00021 |
| MDR Report Key | 429481 |
| Report Source | 08 |
| Date Received | 2002-11-20 |
| Date of Report | 2002-11-20 |
| Date Mfgr Received | 2002-10-21 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2002-11-27 |
| 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 | 2002-11-20 |
| Returned To Mfg | 2002-11-11 |
| Model Number | NA |
| Catalog Number | G0026 |
| Lot Number | 01198N1 |
| ID Number | NA |
| Device Expiration Date | 2003-06-01 |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 418485 |
| 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 | G0026 |
| Baseline ID | 3 GRAMS IN SYRI |
| 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 | 2002-11-20 |