BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASTAR IRRIGATOR

    MDR report key: 1617150 · Received February 22, 2010

    Report

    Report Number
    MW5014895
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 22, 2010
    Manufacturer
    MICROMEDICAL
    Product Code
    LXV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING AUDIOGRAM, EQUIPMENT GENERATED TOO HOT OF WATER BEING IRRIGATED INTO EAR. PATIENT COMPLAINED TEST WAS STOPPED. PATIENT HAD NO FURTHER COMPLAINTS. EQUIPMENT REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASTAR IRRIGATOR IRRIGATOR LXV MICROMEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR