UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05879)
UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05879) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN GEL IMPLANTS; Generic name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI; Manufacturer: MENTOR TEXAS.
| Device | UNKNOWN GEL IMPLANTS |
|---|---|
| Generic name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05879 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 |
| Source | openFDA MAUDE (device adverse events) |
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