FDA Adverse Event
Injury
Summary report: N
UNK MAMMARY IMPLANT
MDR report key: 22468839
·
Received July 10, 2025
Report
- Report Number
- 9617229-2025-11508
- Event Type
- Injury
- Date Received
- July 10, 2025
- Date of Event
- January 1, 2023
- Report Date
- August 12, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE/DEFLATION.
Additional Manufacturer Narrative · 0
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B3, D6B, A6. CLARIFICATIONS TO D6B: PARTIAL IMPLANT DATE(2007)18 YEARS AGO.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE/DEFLATION¿ DIAGNOSED VIA MRI. THE DEVICE HAS BEEN EXPLANTED.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE/DEFLATION¿ DIAGNOSED VIA MRI. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 793140 | UNK MAMMARY IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |