BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK GUIDE, 1.8MM

    MDR report key: 12433457 · Received September 7, 2021

    Report

    Report Number
    2031009-2021-00004
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    TRIMED INC
    Product Code
    LXH
    UDI-DI
    00842188112898
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A TRIMED SALES REPRESENTATIVE REPORTED ON (B)(6) 2021 THAT THE GUIDEQ-1.8 FROM A WRIST FIXATION SET HAD "NOT FOR HUMAN USE" LASER MARKED ON THE BOTTOM OF THE DRILL GUIDE. HE STATED THIS DEVICE WAS FOUND DURING A ROUTINE CHECK OF HIS TRAY AND THAT HE IS UNSURE IF THE DEVICE HAD COME IN CONTACT WITH A PATIENT BUT DOESN'T BELIEVE THIS ISSUE CAUSED ANY ADDITIONAL PATIENT HARM OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334132 QUICK GUIDE, 1.8MM QUICK GUIDE, 1.8MM LXH TRIMED INC GUIDEQ-1.8 BA19001 00842188112898

    Patients

    Seq Age Sex Outcome Treatment
    1 Other