MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-30 for TISSUE BANK INTERNATIONAL * manufactured by Tissue Bank International.
[19891401]
Pt returned to surgery for i & d after placement of allograft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033871 |
| MDR Report Key | 562131 |
| Date Received | 2004-11-30 |
| Date of Report | 2004-11-30 |
| Date of Event | 2004-11-18 |
| Date Added to Maude | 2004-12-30 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TISSUE BANK INTERNATIONAL |
| Generic Name | TIBIALIS TENDON ALLOGRAFT |
| Product Code | LMO |
| Date Received | 2004-11-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CA0404019007 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 551847 |
| Manufacturer | TISSUE BANK INTERNATIONAL |
| Manufacturer Address | * SAN RAFAEL CA 94901 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-30 |