BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 14986532 · Received July 12, 2022

    Report

    Report Number
    9617229-2022-11760
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    March 1, 2022
    Report Date
    September 6, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000223
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. 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: DEFLATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, D9, H3, H6.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON AUGUST 08, 2022, WITH LOT NUMBER 2925416. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING ON POSTERIOR, WEAR ABRASION AND CREASE FOLD. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CREASE SMOOTH OPENING ON POSTERIOR, YELLOW BIOLOGICAL TISSUE INNER THE DEVICE AND OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: OPENING CREASE SMOOTH ON POSTERIOR ASSESSED AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701564 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FWM ALLERGAN (COSTA RICA) 68-330 2925416 10888628000223

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention