BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12489523 · Received September 17, 2021

    Report

    Report Number
    9617229-2021-51966
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    July 29, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002227
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, WAS RECEIVED ON AUG 30, 2021 WITH LOT NUMBER 2991146. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OVERWEIGHT, A CURVED OPENING ON RADIUS, WEAR ABRASION, AND FLAT CREASES. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: A SHARP OPENING WITH WEAR ABRASION NEAR OF THE OPENING SITE, THIS CONDITION WAS CALLED SURGICAL IMPACT. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP OPENING ON RADIUS ASSESSED AS SURGICAL IMPACT. 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: RUPTURE.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER CONFIRMED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390266 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 110-300 2991146 10888628002227

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention