BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20200168 · Received September 12, 2024

    Report

    Report Number
    9617229-2024-20546
    Event Type
    Injury
    Date Received
    September 12, 2024
    Report Date
    September 12, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: INFECTION 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 ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS RELATED TO THE REPORTED EVENT. SEAL STRENGTH WAS SUCCESSFULLY COMPLETED, AND 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 (B)(4) IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR GEL BREAST IMPLANT FAMILY FOR THE PERIOD OF AUGUST 2022 THROUGH JULY 2024, WAS NOTED 1 POINT OUTLIER IN NOVEMBER 2022. THE ADDITIONAL ANALYSIS PERFORMED SHOWS ALL THAT RESULTS MET THE ACCEPTANCE CRITERIA AND NO ISSUES, DEVIATIONS OR NON-CONFORMANCES WERE FOUND WHICH COULD BE ASSOCIATED TO THE INFECTION EVENT, SO, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH INFECTION WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTION TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. 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, AND NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED TO THIS LOT AND THE COMPLAINT, NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT REPORTED "AUTO IMMUNE (NOT DEVICE RELATED), INFECTIONS, DERMATITIS AND SEVERAL OTHER HEALTH ISSUES". AFFECTED SIDE IS RIGHT. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574188 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2951959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention