BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMAPROMPT FG

    MDR report key: 19850022 · Received July 29, 2024

    Report

    Report Number
    19850022
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    March 25, 2024
    Report Date
    March 25, 2024
    Manufacturer
    AERSCHER DIAGNOSTICS
    Product Code
    KHE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HEMAPROMPT FG KIT ~ SCREEN FOR FECAL & GASTRIC BLOOD WITH CONTROL MONITOR AND DEVELOPER. LOT # 263, EXP. DATE: 10/31/2024. THE ENTIRE LOT # IS MISSING THE STICKER THAT IS USUALLY ATTACHED TO THE KIT THAT YOU PULL OFF AND USE FOR THE QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374923 HEMAPROMPT FG REAGENT, OCCULT BLOOD KHE AERSCHER DIAGNOSTICS HPFG 263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown