UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05867)
UNKNOWN GEL IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05867) 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 | 1645337-2020-05867 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD |
| Source | openFDA MAUDE (device adverse events) |
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