UNK GEL BREAST IMPLANT Adverse Event — Injury (MDR 9617229-2020-07135)
UNK GEL BREAST IMPLANT Adverse Event — Injury (MDR 9617229-2020-07135) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNK GEL BREAST IMPLANT; Generic name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI; Manufacturer: ALLERGAN (COSTA RICA).
| Device | UNK GEL BREAST IMPLANT |
|---|---|
| Generic name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI |
| Manufacturer | ALLERGAN (COSTA RICA) |
| Report number | 9617229-2020-07135 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | THE EVENT OF "CAPSULAR CONTRACTURE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE IV. |
| Source | openFDA MAUDE (device adverse events) |
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