FDA Adverse Event
Injury
Summary report: N
STYLE 168 SALINE FILLED BREAST IMPLANT
MDR report key: 20079026
·
Received August 27, 2024
Report
- Report Number
- 9617229-2024-19697
- Event Type
- Injury
- Date Received
- August 27, 2024
- Report Date
- February 4, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 RIGHT SIDE DEVICE DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE I. THE DEVICE HAS BEEN EXPLANTED.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE I. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1493648 | STYLE 168 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |