BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE EXTENSION CABLE

    MDR report key: 3694772 · Received March 20, 2014

    Report

    Report Number
    3694772
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    September 16, 2013
    Report Date
    March 17, 2014
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REMINGTON MEDICAL DISPOSABLE EXTENSION CABLES, REFERENCE #FL-601-97, WITH LOT NUMBERS: 131411 X1, 131021X1, AND 131653 X2 ARE DEFECTIVE ACCORDING TO SURGEON; SCREW DOWN FAS-LOC CONNECTOR DOES NOT OPEN TO ACCEPT THE POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167549 DISPOSABLE EXTENSION CABLE CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECT DSA REMINGTON MEDICAL, INC. FL-601-97 131411

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO