BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12698829 · Received October 26, 2021

    Report

    Report Number
    9617229-2021-54086
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED ONE EXTENDED OPENING, DARK RING AND FLAT CREASES. 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. 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.

    Description of Event or Problem · 0

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

    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: RUPTURE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596676 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1634464

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention