STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2021-06311
- Event Type
- Injury
- Date Received
- April 22, 2021
- Date of Event
- September 15, 2020
- Report Date
- August 31, 2021
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED AN OPENING ON THE ANTERIOR, AND A OPENING ON THE VALVE. A LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED A STRIATED OPENING ON ANTERIOR, A CRACKED OPENING ON VALVE, NON-PENETRATING NICKS, AND NO CLOUDY DEBRIS WERE OBSERVED INSIDE OR OUTSIDE THE DEVICE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS A STRIATED OPENING ASSESSED AS SURGICAL DAMAGE LIKE CONSIST IN THE USE OF SOME SURGICAL TOOL AND A CRACKED VALVE SEAT DIAPHRAGM VALVE.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. FURTHER INVESTIGATION: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER 13815434 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUN 113135 NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR SALINE BREAST IMPLANTS FOR THE PERIOD OF JUN 2019 THROUGH MAY 2021, WAS NOTED AN OUTLIER IN MAR-20. AN ADDITIONAL ANALYSIS WAS PERFORMED TO DETERMINE ANY PATTERN OR ANY SIMILARITIES RELATION BETWEEN PR¿S INVOLVED. IT WAS FOUND THAT SOME PRIMARY PACKAGING OPERATORS WERE INVOLVED IN MORE THAN ONE OCCASION, HOWEVER THE PEOPLE WERE TRAINED IN THE CORRESPONDING PROCEDURE. ALSO, CALIBRATIONS AND MAINTENANCE OF THE EQUIPMENT¿S INVOLVED IN MORE THAN ONE OCCASION WERE REVIEWED AND IT WAS DETERMINED THAT THEY WERE PERFORMED ON TIME AND MET SPECIFICATIONS. IN ADDITION, ALL THE RECORDS INVOLVED IN THIS MONTH WERE REVIEWED AND NO ISSUES WERE FOUND ASSOCIATED TO EITHER EVENT. A REVIEW OF ALL MOLD COMPLAINTS WAS PERFORMED FOR THE PERIOD FROM JUN 2019 THROUGH MAY 2021 AND NO ADVERSE TREND WAS FOUND. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.
PATIENT REPORTED RIGHT SIDE "LEAK." HEALTHCARE PROFESSIONAL REPORTED "IMPLANTS HAD CLOUDY DEBRIS INSIDE. LOOKED LIKE THERE WAS BACTERIA IN THE SALINE, OR MOLD." DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RIGHT SIDE "LEAK." HEALTHCARE PROFESSIONAL REPORTED "IMPLANTS HAD CLOUDY DEBRIS INSIDE. LOOKED LIKE THERE WAS BACTERIA IN THE SALINE, OR MOLD." DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "IMPLANTS HAD CLOUDY DEBRIS INSIDE. LOOKED LIKE THERE WAS BACTERIA IN THE SALINE, OR MOLD." DEVICE HAS BEEN EXPLANTED.
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: DEFLATION.
PATIENT REPORTED RIGHT SIDE "LEAK." DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606805 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1656309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 175 YR | Required Intervention |