BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOCTOR EASY MEDICAL PRODUCTS

    MDR report key: 12370130 · Received August 26, 2021

    Report

    Report Number
    12370130
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 4, 2021
    Manufacturer
    DOCTOR EASY MEDICAL PRODUCTS, LLC
    Product Code
    OGQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ELEPHANT EAR WASHER HAS MALFUNCTIONED 4 TIMES IN THE LAST MONTH. INSTEAD OF EXPRESSING WARM WATER INTO THE EAR CANAL, WE HAVE HAD 4 INSTANCES WHERE IT IS EXPRESSING AIR INSTEAD OF WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266495 DOCTOR EASY MEDICAL PRODUCTS EAR IRRIGATION KIT OGQ DOCTOR EASY MEDICAL PRODUCTS, LLC EI

    Patients

    Seq Age Sex Outcome Treatment
    1