FDA Adverse Event
Injury
Summary report: N
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 20033163
·
Received August 22, 2024
Report
- Report Number
- 9617229-2024-19317
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- June 24, 2024
- Report Date
- December 10, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 · 0
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE "TEXTURED TO SMOOTH EXCHANGE". HEALTHCARE PROFESSIONAL, LATER REPORTED, RUPTURE. PER RGA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED TO SMOOTH EXCHANGE." HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE PER RGA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1219113 | STYLE 115 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1542880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention |