BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMAPROMPT FG

    MDR report key: 5797728 · Received July 15, 2016

    Report

    Report Number
    5797728
    Event Type
    Malfunction
    Date Received
    July 15, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 13, 2016
    Manufacturer
    AERSCHER DIAGNOSTICS
    Product Code
    KHE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ED MANAGER REPORTED THAT THE HEMAPROMPT FG SCREENING TEST KITS ARE DRIED OUT AND NOT USABLE. THEY ARE GIVEN TO A PATIENT TO DO A FECAL AND GASTRIC OCCULT BLOOD SCREEN.

    Description of Event or Problem · 1

    ED MANAGER REPORTED THAT THE HEMAPROMPT FG SCREENING TEST KITS ARE DRIED OUT AND NOT USABLE. THEY ARE GIVEN TO A PATIENT TO DO A FECAL AND GASTRIC OCCULT BLOOD SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451982 HEMAPROMPT FG REAGENT, OCCULT BLOOD KHE AERSCHER DIAGNOSTICS 967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown