BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER PRODUCTS AND SERVICES

    MDR report key: 502135 · Received December 9, 2003

    Report

    Report Number
    MW1030520
    Event Type
    Malfunction
    Date Received
    December 9, 2003
    Date of Event
    November 18, 2003
    Report Date
    December 1, 2003
    Manufacturer
    CARDINAL HEALTH V. MUELLER PRODUCT AND SERVICES
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE PT'S TONSIL USING A SNARE, THE SNARE WIRE BROKE. ALL OF THE WIRE EXCEPT FOR A SMALL PIECE WAS RETRIEVED. THE PHYSICIAN WAS IMMEDIATELY NOTIFIED THAT A SMALL SEGMENT OF THE SNARE WIRE WAS MISSING. A THOROUGH NASOPHARYNX EXAM AND A DIRECT LARYNGOSCOPY WAS PERFORMED. NO FOREIGN BODY WAS VISUALIZED AND CHEST AND NECK X-RAYS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V. MUELLER PRODUCTS AND SERVICES TONSIL WIRES KBZ CARDINAL HEALTH V. MUELLER PRODUCT AND SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other