FDA Adverse Event
Injury
Summary report: N
STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 10691364
·
Received October 16, 2020
Report
- Report Number
- 9617229-2020-16038
- Event Type
- Injury
- Date Received
- October 16, 2020
- Date of Event
- March 13, 2019
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR 1870850 ON 22/APR/19. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED; DEVICE IS SEEN RUPTURED. 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: RUPTURE.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1154711 | STYLE 10 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 306758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |