BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERTRAX

    MDR report key: 3033441 · Received February 14, 2013

    Report

    Report Number
    3033441
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SUPERDIMENSON, LTD.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66535 SUPERTRAX BIOPSY GAA SUPERDIMENSON, LTD. AK100101-01 21 SD06-12-215
    66536 SUPERTRAX BIOPSY DWO SUPERDIMENSON, LTD. AK100101-01 21 15356

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR