BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED V-MOUNT COUPLER

    MDR report key: 118526 · Received September 5, 1997

    Report

    Report Number
    1030489-1997-00112
    Event Type
    Malfunction
    Date Received
    September 5, 1997
    Date of Event
    August 7, 1997
    Report Date
    August 7, 1997
    Manufacturer
    SOFAMAR DANEK MEDICAL, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY COUPLER CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED V-MOUNT COUPLER COUPLER HRX SOFAMAR DANEK MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN