INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-02760
- Event Type
- Injury
- Date Received
- February 20, 2024
- Date of Event
- September 15, 2019
- Report Date
- January 16, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, D.6B, H6.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "SEROMA AND LUMP/NODULE" 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: SEROMA AND LUMP/NODULE.
DEVICE PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ SEROMA-LATE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ LUMP/ NODULE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ HEMATOMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ FLIPPING: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ CREASE/ FOLDING OF IMPLANT: NOT OBSERVED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5; B6; B7; G2; H6.
PATIENT REPORTED LEFT SIDE " A LUMP AROUND THE PROSTHESIS AND A COLLECTION OF FLUID AROUND THE PROSTHESIS" (SEROMA, HEMATOMA), RADIAL FOLDS, AND LEFT IMPLANT SHOWING SIGNS OF ROTATION OF ITS AXES. THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED LEFT SIDE " A LUMP AROUND THE PROSTHESIS AND A COLLECTION OF FLUID AROUND THE PROSTHESIS" (SEROMA, HEMATOMA), RADIAL FOLDS, AND LEFT IMPLANT SHOWING SIGNS OF ROTATION OF ITS AXES. DEVICE REMAINS IMPLANTED.
PATIENT REPORTED LEFT SIDE " A LUMP AROUND THE PROSTHESIS AND A COLLECTION OF FLUID AROUND THE PROSTHESIS" (SEROMA, HEMATOMA), RADIAL FOLDS, AND LEFT IMPLANT SHOWING SIGNS OF ROTATION OF ITS AXES. THE DEVICE HAS BEEN EXPLANTED.
THE DEVICE HAS BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465730 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2884841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female | Required Intervention |