BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELCH ALLYN

    MDR report key: 513931 · Received February 27, 2004

    Report

    Report Number
    1316463-2004-00002
    Event Type
    Injury
    Date Received
    February 27, 2004
    Date of Event
    February 1, 2002
    Report Date
    February 27, 2004
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT'S EAR WAS CLEANED USING A PRESSURIZED EAR WASH SYSTEM. PT ALLEDGEDLY HAS SUSTAINED HEARING LOSS IN THEIR EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELCH ALLYN EAR WASH SYSTEM KYZ WELCH ALLYN, INC. 29300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability