BEUDAMED
    FDA Adverse Event Summary report: N

    TRACTION SCALE ATTACHMENT

    MDR report key: 2651009 · Received July 3, 2012

    Report

    Report Number
    MW5026080
    Date Received
    July 3, 2012
    Report Date
    July 3, 2012
    Manufacturer
    ARTHREX INC.
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PURCHASED A TRACTION SCALE ATTACHMENT FROM ARTHREX INC. PRODUCT NUMBER (B)(4). PRODUCT DEEMED AS A MEDICAL DEVICE. UNDER CLOSER INSPECTION OF DEVICE, FOUND ANOTHER MANUFACTURER AND PRODUCT NUMBER AS (B)(4). A WEB SEARCH OF THIS COMPANY AND MODEL NUMBER REVEALED THAT PRODUCT IS SOLD AS INSTRUMENT SCALES FOR FISHERMAN AND HUNTERS. CLEANING AND STERILIZATION OF MEDICAL DEVICE WAS GENERIC, AND WHEN I CALLED THE COMPANY CUSTOMER SERVICE LINE, AND ASKED FOR CLEANING AND STERILIZATION INSTRUCTIONS SPECIFIC TO THIS DEVICE, WAS TOLD THAT NONE WAS AVAILABLE. VERY CONCERNED THAT COMPANY IS PASSING OFF A NON-MEDICAL DEVICE WAS MEDICAL AND SURGICAL GRADE. THIS ITEM IS USED IN THE STERILE FIELD, IN SHOULDER TRACTION SURGERY, AND I'M AFRAID SOMEONE WILL BE INJURED, OR THE STERILE FIELD CONTAMINATED BY INEFFECTUAL CLEANING, AND STERILIZATION OF A NON-MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACTION SCALE ATTACHMENT TRACTION SCALE FRW ARTHREX INC. AR-1604

    Patients

    Seq Age Sex Outcome Treatment
    1