BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEPHANT EAR WASHER

    MDR report key: 407722 · Received July 26, 2002

    Report

    Report Number
    407722
    Event Type
    Malfunction
    Date Received
    July 26, 2002
    Date of Event
    June 17, 2002
    Report Date
    July 16, 2002
    Manufacturer
    FLAT MOP CORP
    Product Code
    JYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF WASHER SEPARATED FROM THE ATTACHED CONNECTION TO WASHER BOTTLE. CATHETER-LIKE TIP LODGED IN EAR CANAL AND WAS REMOVED BY PHYSICIAN. EARDRUM WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEPHANT EAR WASHER EAR WASHER TIP JYC FLAT MOP CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other