BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14640789 · Received June 9, 2022

    Report

    Report Number
    9617229-2022-09174
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    April 29, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). (B)(4). 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. THE REASON FOR REOPERATION IS: UNILATERAL RIGHT SIDE RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, WAS RECEIVED ON (B)(6) 2022. WITH LOT NUMBER 1252903. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED. UNDERWEIGHT, AN OPENING ON RADIUS, WEAR ABRASION, AND CREASE FOLD. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED, A CREASE SHARP OPENING ON RADIUS AND STRESS MARKS. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS: A CREASE SHARP OPENING ON RADIUS ASSESSED, AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED UNILATERAL RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, "UNILATERAL RIGHT SIDE RUPTURE". THE DEVICE HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679905 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1252903

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention