BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STYLE SCX

    MDR report key: 10641847 · Received October 7, 2020

    Report

    Report Number
    9617229-2020-16480
    Event Type
    Injury
    Date Received
    October 7, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    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. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN UNKNOWN SIDE RUPTURE. DEVICE REMAINS IMPLANTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109440 UNK STYLE SCX PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention