MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-17 for PROFESSOR COSTAGLIOLA'S MAMMOSTAT AC/006 manufactured by Bpsp Co Dba Medical Z.
[420988]
Company provided inadequate sterilization parameters for their product. "pre-vac. Steam sterilization at 273f. For 4 minutes or vacuum autoclave sterilization at 273f. For 4 to 20 minutes for hard goods -non-wrapped- at 2 bars - 29psi-. " verbal contact with mfr indicated that there are no other modalities for sterilization that have been approved or tested. Surgical procedure breast reduction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037551 |
| MDR Report Key | 662153 |
| Date Received | 2005-11-17 |
| Date of Report | 2005-11-17 |
| Date Added to Maude | 2006-01-12 |
| 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 | PROFESSOR COSTAGLIOLA'S MAMMOSTAT |
| Generic Name | MAMMOSTAT |
| Product Code | KMO |
| Date Received | 2005-11-17 |
| Model Number | MAMMOSTAT |
| Catalog Number | AC/006 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 651563 |
| Manufacturer | BPSP CO DBA MEDICAL Z |
| Manufacturer Address | 6800 ALAMO DOWNS PARKWAY SAN ANTONIO TX 78238 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-17 |