MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-10 for CRYOLIFE SEMITENDINOSUS ALLOGRAFT ACL UNK manufactured by Cryolife.
[361815]
Cryolife mfr or donor tissues, tried to recall a semitendinosous graft deemed to have been screened for microbiological contaminant. Cryolife had no record that the graft had already been implanted in pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032459 |
| MDR Report Key | 537560 |
| Date Received | 2004-06-14 |
| Date of Report | 2004-06-10 |
| Date of Event | 2004-05-10 |
| Date Added to Maude | 2004-08-05 |
| 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 | PATIENT |
| 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 | CRYOLIFE SEMITENDINOSUS ALLOGRAFT |
| Generic Name | ALLOGRAFT TISSUE |
| Product Code | LMO |
| Date Received | 2004-06-10 |
| Model Number | ACL |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 526809 |
| Manufacturer | CRYOLIFE |
| Manufacturer Address | * * GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-14 |