STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-22713
- Event Type
- Injury
- Date Received
- October 16, 2024
- Date of Event
- September 18, 2024
- Report Date
- December 19, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, B3, B5, D6B, H6.
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: D9 H3 H6. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION WAS RECEIVED ON NOV 19, 2024 WITH LOT NUMBER 2060578. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: DEFLATION: OBSERVED 3 OPENINGS ASSESSED AS SURGICAL DAMAGE. OBSERVED AN OPENING ASSESSED AS FOLD FLOW OPENING. AS PER THE INVESTIGATION PROCEDURE CREASES AND WEAR ABRASION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION." RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION." RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1352600 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 2060578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Required Intervention |