MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-04 for MEDIFIL GEL * manufactured by Biocare Medical Technologies, Inc..
[133682]
Device stored at room temperature per mfrs instructions. Device noted to be severly discolored. No shelf life data available from mfr in spite of consultant advice accordingly. Multiple samples changed within alleged expiration date. Mfr notified by telephone 1 mo after event, they then stated that storage conditions to blame. No eval of material by mfr. Possibility of proper facility follow up for this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013770 |
| MDR Report Key | 167370 |
| Date Received | 1998-05-04 |
| Date of Report | 1998-05-04 |
| Date of Event | 1998-04-22 |
| Date Added to Maude | 1998-05-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIFIL GEL |
| Generic Name | COLLAGEN |
| Product Code | LMI |
| Date Received | 1998-05-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MULTIPLE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 162869 |
| Manufacturer | BIOCARE MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 1605 S.W. 41ST ST. TOPEKA KS 66609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-05-04 |