STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-02841
- Event Type
- Injury
- Date Received
- March 8, 2022
- Report Date
- September 11, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191600958
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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, CHANGED, AND/OR CORRECTED DATA: B5, D6B, G1, H6.
LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON AUGUST 09, 2024, WITH LOT NUMBER 2935927. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: NOT OBSERVED. AS PER THE INVESTIGATION PROCEDURE DEFORMATION PARTICLES WEAR ABRASION CREASE WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
PATIENT REPORTING A SUSPECTED RUPTURE OF THE RIGHT DEVICE. DEVICE REMAINS IMPLANTED.
THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTING A SUSPECTED RUPTURE OF THE RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1429631 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 380665 | 05060191600958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |