BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2092944 · Received May 10, 2011

    Report

    Report Number
    1644408-2011-00273
    Event Type
    Other
    Date Received
    May 10, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ALL THE IMPLANTS WERE GOOD, THE CUFF FAILED. THE SURGEON REMOVED ALL THE IMPLANTS (A TOTAL) AND CONVERTED TO A REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN NA ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention