BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9732561 · Received February 20, 2020

    Report

    Report Number
    9617229-2020-01916
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    April 16, 2019
    Report Date
    July 28, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628033177
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION: REVIEW OF DHR FOR WORK ORDER 3151869 DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE EVENT. ALL GEL BREAST IMPLANTS WERE REVIEWED AS PART OF THE ASSEMBLY OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT ASSEMBLY MET THE REQUIRED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THE DEVICE WEIGHT WITHIN SPECIFICATION, CREASE FOLDS, AND DEFORMATION. A SPLIT IN THE PATCH AREA WAS OBSERVED; THIS WAS ASSESSED AS OUT OF SPECIFICATION AND CHARACTERIZED AS A WORKMANSHIP. CLOUDY IN THE GEL WAS OBSERVED AFTER AUTOCLAVE CYCLE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT WAS SPLIT IN PATCH AREA ASSESSED AS A WORKMANSHIP. A FURTHER INVESTIGATION WAS INITIATED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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 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. THE REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III/IV. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197823 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SSF-450 3151869 10888628033177

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention