MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-20 for SILICONE INJECTOR manufactured by Unknown.
[19803]
Several infections of silicone were made into each breast & substance silicone has separated into small floating particles in the breast area. Dr unable to evaluate mammograms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000726 |
| MDR Report Key | 26963 |
| Date Received | 1995-07-20 |
| Date of Report | 1995-03-01 |
| Date of Event | 1964-01-01 |
| Date Added to Maude | 1995-10-13 |
| 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 | SILICONE INJECTOR |
| Generic Name | INJECTOR |
| Product Code | KGM |
| Date Received | 1995-07-20 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27748 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1995-07-20 |