MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-09 for TIBIALIS TENDON POSTERIOR ID#034649-106 * manufactured by Allosource Customer Service Department.
[20990676]
This is a suspect case of aspergillus of knee graft. Specimen is an implanted cadaveric anterior cruciate ligament obtained through a national donor co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032532 |
| MDR Report Key | 540494 |
| Date Received | 2004-06-10 |
| Date of Report | 2004-06-09 |
| Date of Event | 2004-01-29 |
| Date Added to Maude | 2004-08-26 |
| 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 |
| 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 | TIBIALIS TENDON POSTERIOR |
| Generic Name | TIBIALIS TENDON POSTERIOR |
| Product Code | LMO |
| Date Received | 2004-06-09 |
| Model Number | ID#034649-106 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PC#41617000 |
| Device Expiration Date | 2008-11-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 529801 |
| Manufacturer | ALLOSOURCE CUSTOMER SERVICE DEPARTMENT |
| Manufacturer Address | 6278 S TROY CIRCLE ENGLEWOOD CO 80111 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-10 |