INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-18268
- Event Type
- Injury
- Date Received
- August 6, 2024
- Report Date
- December 28, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. 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.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURED AND TEXTURED" DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURED AND TEXTURED" DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
UPON FURTHER REVIEW, THIS RECORD IS A DUPLICATE OF CN-083313 IN REGARD TO SN (B)(6). ALL RELEVANT INFORMATION FROM THIS RECORD WILL BE TRANSFERRED TO CN-083313 AND THIS RECORD WILL BE UN-REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1572896 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2868678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |