BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10463237 · Received August 27, 2020

    Report

    Report Number
    9617229-2020-13278
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    January 15, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ALLERGAN IS NOT REQUESTING THE DEVICE RETURN AT THIS TIME DUE TO GLOBAL SAFETY CONCERNS ASSOCIATED WITH COVID-19. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE IS SEEN INTACT. DEVICE PATCH WITH LOT NUMBER: 221552 MM-215G. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 1

    PHARMACIST REPORTS LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925907 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 221552

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention