BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR WASH SYSTEM PLUS

    MDR report key: 551046 · Received October 22, 2004

    Report

    Report Number
    1316463-2004-00010
    Event Type
    Injury
    Date Received
    October 22, 2004
    Report Date
    October 13, 2004
    Manufacturer
    WELCH ALLYN
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED HEMORRHAGING IN BOTH OF A PT'S EARS AFTER THEIR EARS WERE CLEANED WITH A WELCH ALLYN EAR WASH SYSTEM PLUS. THEY RETURNED AFTER THEIR EARS WERE CLEANED WITH "CAKED" BLOOD IN BOTH EARS. THE DATE OF THE EVENT IS UNKNOWN. FIRST THE DR REPORTED 08/2002 AND LATER 08/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAR WASH SYSTEM PLUS EAR WASH KYZ WELCH ALLYN 29350 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other