BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14430771 · Received May 18, 2022

    Report

    Report Number
    9617229-2022-07979
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 13, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628001480
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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. REASON FOR REOPERATION: RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED ONE EXTENDED OPENING. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE SHARP EDGE OPENING IN THE SHELL WITH STRESS MARKS AND BROKEN STRIATED. 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 EDGE OPENING IN THE SHELL WITH STRESS MARKS IN THE SIDE POSTERIOR ASSESSED AS SURGICAL IMPACT OPENING. A STRIATED EDGE BROKEN IN THE SIDE RADIUS ASSESSED AS SURGICAL DAMAGE. MISSING SHELL ASSESSED AS INCONCLUSIVE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710037 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 15-397 2799216 10888628001480

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention