FDA Adverse Event
Injury
Summary report: N
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 21799512
·
Received April 8, 2025
Report
- Report Number
- 9617229-2025-05767
- Event Type
- Injury
- Date Received
- April 8, 2025
- Report Date
- July 8, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191607285
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 003
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.
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
Description of Event or Problem · 0
PATIENT REPORTED RIGHT SIDE RUPTURE AND "PREGNANCY WITH A RETRO-AREOLAR 0.5 CM NODULATION IN QSE. BREAST PROSTHESIS". THE EVENT OF NODULATION IS NOT CONSIDERED DEVICE RELATED. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 0
LATER HEALTHCARE PROFESSIONAL REPORTED "EXTENSIVE INTRACAPSULAR RUPTURE" DIAGNOSED VIA MRI AND ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543020 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2671365 | 5060191607285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |