FDA Adverse Event
Injury
Summary report: N
STYLE 68 SALINE FILLED BREAST IMPLANT
MDR report key: 15888999
·
Received November 30, 2022
Report
- Report Number
- 9617229-2022-21213
- Event Type
- Injury
- Date Received
- November 30, 2022
- Date of Event
- May 18, 2022
- Report Date
- November 30, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- UDI-DI
- 10888628000322
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INITIAL REPORTER- FAX: +1(954)564-1725. INITIAL REPORTER- FAX: +1(954)565-4162. INITIAL REPORTER- FAX: +1(954)564-1721. 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: DEFLATION.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2464763 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 68-700 | 2694674 | 10888628000322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |