BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11788282 · Received May 6, 2021

    Report

    Report Number
    9617229-2021-06793
    Event Type
    Injury
    Date Received
    May 6, 2021
    Report Date
    February 1, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628032972
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON (B)(6) 2021, WITH LOT NUMBER 3181696. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, WEIGHT TO THE SPEC, CREASE FOLD AND DEVICE APPEARANCE (OBSERVED SPLIT IN PATCH AREA). A SEPARATION BETWEEN THE PATCH AND THE SHELL IS OBSERVED, ACCORDING TO QA199.04 UNDER THE SS CODE. CLOUDY WAS OBSERVED, AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS: OBSERVED SEPARATION IN THE PATH AND SHELL ACCORDING TO QA199.04 UNDER THE SS CODE IS CONSIDERED WORKMANSHIP.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS, INDICATES THAT ALL DEVICES WERE RELEASED IN ACCORDANCE WITH THE CURRENT MANUFACTURING PROCEDURES. AND NO ANOMALIES WERE FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED IN THE LABORATORY, IT WAS FOUND, A SPLIT IN PATCH AREA (SS). WHICH IS CONSIDERED, AS WORKMANSHIP. THIS FINDING IS NOT RELATED WITH THE REPORTED EVENT. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED, AND THE EVENT OF SPLIT IN PATCH AREA IS A KNOWN EVENT. FOR WHICH MANUFACTURING PROCESS CONTROLS AND INSPECTIONS ARE STABLISHED TO REDUCE THE INCIDENCE OF THIS DEFECT. CONSIDERING, THAT THERE IS NOT ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH SPLIT IN PATCH AREA WILL CONTINUE TO BE MONITORED. AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN REPLACED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE 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: CAPSULAR CONTRACTURE BAKER GRADE IV.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684686 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SSM-445 3181696 10888628032972

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention