BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNOMED EUROPE

    MDR report key: 12974279 · Received December 10, 2021

    Report

    Report Number
    9710376-2021-00003
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 8, 2021
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375861547
    PMA / PMN Number
    K130136
    Removal / Correction Number
    RES# 89126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PROBLEM OCCURRED WITH THE SECOND CORKSCREW THEY USED DURING THE PROCEDURE, THE FIRST ONE WENT FINE. THE USER INSERTED IT A HALF TURN, BUT IT COULD NOT BE INSERTED COMPLETELY INTO THE SKIN AS THE HUB STARTED TURNING. SHE HAD NO GRIP ON THE NEEDLE ANYMORE. THEN, SHE TRIED TO PULL IT OUT, BUT THE NEEDLE DID NOT COME OUT DUE TO LACK OF GRIP BECAUSE OF THE LOOSE HUB. THE SURGEON WAS IN A HURRY, WHICH IS WHY THEY PLACED A NEW CORKSCREW AND LEFT THE DEFECTIVE ONE AS IS. AFTER THE SURGERY, THE SURGEON USED A LITTLE SURGICAL INSTRUMENT (FORCEPS) TO REMOVE THE NEEDLE. 1MM AT A TIME, HE PULLED IT OUT. THE PATIENT BLED QUITE A LOT AFTER THE NEEDLE CAME OUT. THE NEEDLE WAS STILL ATTACHED TO THE LEAD WIRE. DUE TO USING PRESSURE, THE NEEDLE WAS DEFORMED. THE WOUND WAS STAUNCHED AND BLEEDING STOPPED AFTER A WHILE. NO STITCHING WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875409 TECHNOMED EUROPE DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, CORKSCREW GXZ TECHNOMED EUROPE TE/S50715-001 049989 OR 049528 08718375861547

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other