INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-01896
- Event Type
- Injury
- Date Received
- February 4, 2025
- Date of Event
- February 14, 2017
- Report Date
- February 5, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H10 THIS REPORT HAS BEEN CONFIRMED AS A DUPLICATE OF MRN 9617229-2025-0000026 AND WAS INITIALLY REPORTED IN ERROR. SEE RELATED MRN FOR ALL RELEVANT INFORMATION.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: "PERI-IMPLANT FLUID ACCUMULATION".
THIS REPORT HAS BEEN CONFIRMED AS A DUPLICATE OF MRN 9617229-2025-0000026 AND WAS INITIALLY REPORTED IN ERROR. SEE RELATED MRN FOR ALL RELEVANT INFORMATION.
PATIENT REPORTED "PERI-IMPLANT FLUID ACCUMULATION" DIAGNOSED BY MRI AND ULTRASOUND. HEALTHCARE PROFESSIONAL CONFIRMS "FLUID COLLECTION, CAUSING LOCALIZED PAIN AND SYSTEMIC ILLNESS." AFFECTED SIDE IS RIGHT. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64158 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2700182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Required Intervention |