MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-29 for ALLOGRAFT PATCH * manufactured by Cryolife.
[16767159]
Cryolife tissue implanted into right main pulmonary artery. Cultured for bacteria at time of implant, 22 hours later reported as for mrsa -methicillin resistant staph aureus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034218 |
| MDR Report Key | 565261 |
| Date Received | 2004-12-29 |
| Date of Report | 2004-12-29 |
| Date of Event | 2000-11-18 |
| Date Added to Maude | 2005-01-14 |
| 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 CAREGIVERS |
| 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 | ALLOGRAFT PATCH |
| Generic Name | TISSUE |
| Product Code | LMO |
| Date Received | 2004-12-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 8324410 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555029 |
| Manufacturer | CRYOLIFE |
| Manufacturer Address | * KENNESAW GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2004-12-29 |