BEUDAMED
    FDA Adverse Event Other Summary report: N

    KUHN 90 ASPIRATOR

    MDR report key: 843385 · Received May 1, 2007

    Report

    Report Number
    1225258-2007-00021
    Event Type
    Other
    Date Received
    May 1, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 1, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT THE CURRENT CLEANING PROBE FOR THE ASPIRATOR AND THE PROCESS FOR USING IT CAN CAUSE THE OUTSIDE DIAMETER OF THE PLASTIC TO BE SHAVED OFF. THERE HAS BEEN NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUHN 90 ASPIRATOR ASPIRATORS LLZ GE OEC MEDICAL SYSTEMS, INC. 1000543-NAV 43337

    Patients

    Seq Age Sex Outcome Treatment
    1 YR