BEUDAMED
    FDA Adverse Event Other Summary report: N

    DLP-W11

    MDR report key: 1000490 · Received January 24, 2008

    Report

    Report Number
    1718873-2008-00001
    Event Type
    Other
    Date Received
    January 24, 2008
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    KNS
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY THE MEDICAL FACILITY AS A PROD PROBLEM. NOT AN ADVERSE EVENT. PROCEDURE WAS COMPLICATED BY HEMORRHAGE AND COLLATERAL TISSUE DAMAGE. THE CAUSE OF THE COLLATERAL DAMAGE COULD NOT BE DETERMINED BY THE MEDICAL PRACTITIONERS. IN THE ABSENCE OF A TRAINED CLINICIAN INDICATION OF RISK OF SERIOUS INJURY, UTMD IS UNABLE TO DETERMINE THE LIKELY HOOD OF SERIOUS INJURY. IF THE EVENT WERE TO RECUR AS NO PRIOR SERIOUS INJURIES HAVE BEEN REPORTED USING THIS DEVICE OVER 16 YRS. THE PT APPARENTLY WENT HOME WITHOUT SERIOUS INJURY. MORE PT INFO IS NEEDED. THE CAUSE OF THE WIRE SEVER COULD NOT BE DETERMINED BY UTMD. CORRECTION: DATE OF EVENT WAS 2007 ACCORDING TO THE HOSP OPERATION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP-W11 LOOP ELECTRODE KNS UTAH MEDICAL PRODUCTS, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1