BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12542975 · Received September 28, 2021

    Report

    Report Number
    9617229-2021-52562
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    May 12, 2010
    Report Date
    October 2, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(6) 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 112374 IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR GEL BREAST IMPLANTS FOR THE PERIOD OF SEP 2019 THROUGH AUG 2021, WAS NOTED AN OUTLIER IN NOV 19. AN ADDITIONAL ANALYSIS WAS PERFORMED TO DETERMINE ANY PATTERN OR ANY SIMILARITIES RELATION BETWEEN PRS INVOLVED. IT WAS FOUND THAT SOME SEALERS WERE INVOLVED IN MORE THAN ONE OCCASION, HOWEVER, CALIBRATIONS AND MAINTENANCE OF THE EQUIPMENT INVOLVED 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. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT REPORTS RIGHT SIDE INFECTION. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON (B)(6) 2011. 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. THE REPORTED EVENTS OF "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND "INFECTION" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: INFECTION, "CAPSULAR CONTRACTURE, BAKER GRADE IV"

    Description of Event or Problem · 1

    PATIENT REPORTS RIGHT SIDE INFECTION. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439188 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1625596

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention