MENTOR MEMORYSHAPE BREAST IMPLANT Adverse Event — Injury (MDR 1645337-2020-05467)
MENTOR MEMORYSHAPE BREAST IMPLANT Adverse Event — Injury (MDR 1645337-2020-05467) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MENTOR MEMORYSHAPE BREAST IMPLANT; Generic name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI; Manufacturer: MENTOR TEXAS.
| Device | MENTOR MEMORYSHAPE BREAST IMPLANT |
|---|---|
| Generic name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05467 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WER |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →