BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTAH MEDICAL PRODUCTS, INC.

    MDR report key: 967398 · Received February 8, 2006

    Report

    Report Number
    967398
    Event Type
    Malfunction
    Date Received
    February 8, 2006
    Date of Event
    January 31, 2006
    Report Date
    February 7, 2006
    Manufacturer
    UTAH MEDICAL PRODUCTS INC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UTAH LOOP BROKE IN HALF DURING CERVICAL LESION/LEEP PROCEDURE-STOPPED USE OF LOOP. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTAH MEDICAL PRODUCTS, INC. LETZ LOOP ELECTRODE WITH SAFE-T GAUGE KNS UTAH MEDICAL PRODUCTS INC DLP-L11 151902

    Patients

    Seq Age Sex Outcome Treatment
    1 YR