BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNOMED EUROPE

    MDR report key: 22574502 · Received July 23, 2025

    Report

    Report Number
    9710376-2025-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 23, 2025
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    IKT
    PMA / PMN Number
    K130136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TECHNOMED RECEIVED REPORT VIA THIRD PARTY DISTRIBUTOR (B)(4) ON 26 JUNE 2025. THE DOCTORS WAS USING A TECHNOMED NEEDLE ON A PATIENT, AND THE NEEDLE BROKE AWAY FROM THE HUB. THE NEEDLE WAS STILL INSIDE THE PATIENT'S SKIN. THE DOCTOR TOOK MEASURES TO MINIMIZE THE SITUATION AND TO NOT ALARM THE PATIENT. HE HAD IMMEDIATELY PUT THE NEEDLE AND HUB INTO THE SHARPS CONTAINER, SO THEY DO NOT HAVE IT TO SEND BACK TO (B)(4). THIS DOCTOR IS VERY GENTLE AND DOESN'T PUT THE NEEDLE VERY FAR UNDER THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938477 TECHNOMED EUROPE DISPOSABLE MONOPOLAR NEEDLE ELECTRODE - PENCIL POINT 37MM 28G IKT TECHNOMED EUROPE TE/AD3735-008

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male