BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8812855 · Received July 22, 2019

    Report

    Report Number
    9617229-2019-09121
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 22, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628030121
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE LOT NUMBER 3160451 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN MEDICAL PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. ONE ADDITIONAL COMPLAINT WAS NOTED FOR DEVICES STERILIZED UNDER STERILIZATION RUN (B)(4). 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 ALLERGAN 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. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR GEL BREAST IMPLANTS FOR THE PERIOD OF JUL 2017 THROUGH JUN 2019, WAS NOTED AN OUTLIER IN NOVEMBER 2017. 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, MAINTENANCE AND VALIDATIONS OF THE EQUIPMENTS 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 WAS REVIEWED AND NO ISSUES, DEVIATIONS OR NCS WERE FOUND ASSOCIATED TO EITHER EVENT. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO (B)(4) MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION DUE TO INFECTION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION." DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605994 INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3160451 10888628030121

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention