BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 335805 · Received May 29, 2001

    Report

    Report Number
    1720381-2001-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2001
    Date of Event
    May 1, 2001
    Report Date
    May 3, 2001
    Manufacturer
    FISMA
    Product Code
    HLI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIO TECH REPORTED TO FISMA (HGM) THAT A DOCTOR AT HOSPITAL STATED HE HAD RECEIVED FLASHBACK BECAUSE INDIRECT OPHTHALMOSCOPE MALFUNCTIONED. THE DOCTOR WAS NOT HARMED, BUT WAS UPSET. THE PROCEDURE WAS COMPLETED AND THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS RETURNED TO THE FACTORY FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24829 HGM INDIRECT OPHTHALMOSCOPE HLI FISMA I19-B-A01-1-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other