BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HANDLE COVER

    MDR report key: 7658558 · Received July 3, 2018

    Report

    Report Number
    7658558
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 22, 2018
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAMERA HANDLE COVER FELL OFF DURING SURGICAL PROCEDURE INTO PATIENT WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502214 CAMERA HANDLE COVER SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA ADVANCE MEDICAL DESIGNS, INC. 06-CLK03 70232C7081

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA