BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TRAK GALAXY SYSTEM GAMMA RAY DETECTOR

    MDR report key: 14488208 · Received May 23, 2022

    Report

    Report Number
    MW5109843
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    CARE WISE MEDICAL PRODUCTS CORP / SOUTHERN SCIENTIFIC LTD.
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE SYSTEM IS USED TO DETECT GAMMA RAYS TO IDENTIFY SENTINEL NODES. DEVICE FAILED/MALFUNCTIONED MANUFACTURER NOTIFIED, SENT OUT FOR REPAIR. RETURNED '5/4' WITH MANY INTERNAL FAILURES NOTED BY MANUFACTURER THAT WERE RECTIFIED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219453 C-TRAK GALAXY SYSTEM GAMMA RAY DETECTOR PROBE, UPTAKE, NUCLEAR IZD CARE WISE MEDICAL PRODUCTS CORP / SOUTHERN SCIENTIFIC LTD. CW 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown