BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 306221 · Received November 17, 2000

    Report

    Report Number
    1720381-2000-00005
    Event Type
    Malfunction
    Date Received
    November 17, 2000
    Date of Event
    January 1, 2000
    Report Date
    November 15, 2000
    Manufacturer
    FISMA
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SHUTTER INTERMITTENTLY DID NOT CLOSE COMPLETELY THUS EXPOSING THE DOCTOR AND ASSISTANT. THE DOCTOR REPORTED THAT THIS MALFUNCTION HAD HAPPENED SEVERAL TIMES OVER THE PAST FEW MONTHS. THERE WERE NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM SHUTTER LQJ FISMA K10-A-K03-1-73 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other