BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16872336 · Received May 4, 2023

    Report

    Report Number
    9617229-2023-07617
    Event Type
    Injury
    Date Received
    May 4, 2023
    Report Date
    May 4, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628003187
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: "BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ANXIETY-PRODUCT/PROCEDURE AND INFECTION UNKNOWN ONSET: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: DEFORMATION OBSERVED ON THE DEVICE. YELLOW PARTICLE OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.". FURTHER INVESTIGATION: "WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT LOT NUMBER 2833885 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND THERE WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS RELATED TO THE REPORTED EVENT. 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. AN ADDITIONAL COMPLAINT WAS NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN 30021447. HOWEVER, IT IS UNLIKELY THAT THE EVENTS RELATED TO THE REPORTED INFECTION ARE ASSOCIATED TO THE STERILIZATION METHODS UTILIZED. THE TERMINAL STERILIZATION CYCLE USED BY ABBVIE WAS DEVELOPED AND VALIDATED TO ACHIEVE A HIGH LEVEL OF STERILITY ASSURANCE. THE STERILIZATION CYCLE HAS BEEN VALIDATED TO ASSURE THAT THE CHANCE OF A NON-STERILE DEVICE IS LESS THAN ONE IN A MILLION.". THE EVENT OF "IMPLANT COVERED IN BIOFILM" 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: "CONCERNS OF THE PRODUCT".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE " CONCERNS OF THE PRODUCT". PHYSICIAN LATER NOTED "IMPLANT COVERED IN BIOFILM." DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543386 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) LL-410180 2833885 10888628003187

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention