BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 12206505 · Received July 21, 2021

    Report

    Report Number
    9617229-2021-47711
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION/CREASE FOLDING OF IMPLANT RECEIVED ON (B)(6) 2021 WITH LOT NUMBER 2061711. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING, WEAR ABRASION, CREASE FOLD. LEAK TEST WAS PERFORMED AND FOUND OPENING ON POSTERIOR. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY CREASE SHARP OPENING ON POSTERIOR. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A CREASE SHARP OPENING ON POSTERIOR ASSESSED AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101846 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2061711

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention