BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE EAR WASHER TIPS

    MDR report key: 16662693 · Received April 3, 2023

    Report

    Report Number
    16662693
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 30, 2023
    Manufacturer
    DOCTOR EASY MEDICAL PRODUCTS CORPORATION
    Product Code
    OGQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE RHINO ELEPHANT EAR WASHER SINGLE USE TIP, DETACHED FROM ORIGINAL ATTACHMENT PIECE CONNECTING TO ELEPHANT SPRAY WASHER WHICH BROKE OFF IN PATIENT'S EAR. THE PHYSICIAN WAS ADVISED, AND HE WAS ABLE TO REMOVE THE PLASTIC TIP WITH FORCEPS. NO OTHER CONCERNS OR HARM TO THE PATIENT PER PHYSICIAN. MANUFACTURER RESPONSE FOR EAR WASHER TIP, DISPOSABLE EAR WASHER TIPS (PER SITE REPORTER) E-MAIL TO VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529162 DISPOSABLE EAR WASHER TIPS EAR IRRIGATION KIT OGQ DOCTOR EASY MEDICAL PRODUCTS CORPORATION NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6570 DA Female