BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11368432 · Received February 23, 2021

    Report

    Report Number
    9617229-2021-01752
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 21, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000421
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON APR 12, 2017 WITH LOT 2884277. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENINGS, CREASE FOLD, WEAR ABRASION. LEAK TEST WAS PERFORMED AND FOUND OPENING ON ANTERIOR SIDE. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED A STRIATED EDGE OPENING, CONSISTENT WITH THE USE OF A SURGICAL TOOL. THE FILL TEST INSPECTION WAS PERFORMED, AND THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: TWO STRIATED EDGE OPENINGS ON ANTERIOR AND RADIUS SIDE ASSESSED AS SURGICAL DAMAGE."

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS 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
    264124 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 68HP-425 2884277 10888628000421

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention