UNKNOWN SALINE IMPLANTS TEXTURED Adverse Event — Injury (MDR 1645337-2020-05911)
UNKNOWN SALINE IMPLANTS TEXTURED Adverse Event — Injury (MDR 1645337-2020-05911) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN SALINE IMPLANTS TEXTURED; Generic name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE; Manufacturer: MENTOR TEXAS.
| Device | UNKNOWN SALINE IMPLANTS TEXTURED |
|---|---|
| Generic name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05911 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | FOREIGN, USER FACILITY |
| Narrative | DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION OF THE DEVICE, SILTEX CRACKING WAS OBSERVED ON THE POSTERIOR ASPECT. ADDITIONALLY A TEAR WITHIN THE SILTEX CRACKING MEASURING APPROXIMATELY 0.5 CM WAS NOTED. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. SILTEX CRACKING IS ULTIMATELY A RESULT OF H |
| Source | openFDA MAUDE (device adverse events) |
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