MENTOR SMOOTH ROUND MODERATE PROFILE Adverse Event — Injury (MDR 1645337-2020-05917)
MENTOR SMOOTH ROUND MODERATE PROFILE Adverse Event — Injury (MDR 1645337-2020-05917) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MENTOR SMOOTH ROUND MODERATE PROFILE; Generic name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE; Manufacturer: MENTOR TEXAS.
| Device | MENTOR SMOOTH ROUND MODERATE PROFILE |
|---|---|
| Generic name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05917 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, USER FACILITY |
| Narrative | THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON OCTOBER 19, 2020. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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