MENTOR SMOOTH ROUND HIGH PROFILE Adverse Event — Injury (MDR 1645337-2020-05914)
MENTOR SMOOTH ROUND HIGH PROFILE Adverse Event — Injury (MDR 1645337-2020-05914) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MENTOR SMOOTH ROUND HIGH PROFILE; Generic name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE; Manufacturer: MENTOR TEXAS.
| Device | MENTOR SMOOTH ROUND HIGH PROFILE |
|---|---|
| Generic name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05914 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | ON (B)(6) 2020, MENTOR RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: -THE PATIENT WAS CONFIRMED TO HAVE NOT EXPERIENCED CAPSULAR CONTRACTURE. -THE PATIENT HAS NOT UNDERGONE EXPLANTATION AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED CONFIRMING A DATE OF EXPLANTATION, A SUMMARY REPORT WILL BE SENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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