MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-16 for SPECTRUM DESIGNS PECTORAL IMPLANT UNK manufactured by Spectrum Designs Medical.
[299729]
Spectrum designs medical sold a pair of pectoral implants directly to the reporter, they came in 'sterile' condition. The reporter does not think their implants were properly sterilized and their wounds became infected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027294 |
| MDR Report Key | 438756 |
| Date Received | 2003-01-16 |
| Date of Report | 2003-01-16 |
| Date of Event | 2003-01-08 |
| Date Added to Maude | 2003-01-23 |
| 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 | 0 |
| 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 | SPECTRUM DESIGNS PECTORAL IMPLANT |
| Generic Name | MALE PECTORALIS IMPLANT |
| Product Code | MIC |
| Date Received | 2003-01-16 |
| Returned To Mfg | 2002-01-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 427677 |
| Manufacturer | SPECTRUM DESIGNS MEDICAL |
| Manufacturer Address | 6387-B ROSE LN. CARPINTERIA CA 93013 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-01-16 |