BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLON

    MDR report key: 516125 · Received March 4, 2004

    Report

    Report Number
    MW1031437
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    March 3, 2004
    Report Date
    March 4, 2004
    Manufacturer
    SOLON MFG CO
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE CLEANING JP DRAIN SITE WITH COTTON TIPPED APPLICATOR, COTTON TIP DISCONNECTED FROM APPLICATOR AND WAS RETAINED IN ABDOMEN. LATER RETRIEVED BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLON COTTON TIPPED APPLICATOR KXG SOLON MFG CO * L15833

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other