BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFLEX

    MDR report key: 11250305 · Received January 29, 2021

    Report

    Report Number
    3016567401-2021-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 29, 2021
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    MIJ
    UDI-DI
    04250195611574
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING THE REMOVAL OF A SUSPECTED BREAST LESION THE MARKING WIRE TUFLEX WAS TAPPED WITH A CAUTERY DEVICE (BOVIE) AND IT SPLINTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151553 TUFLEX TUFLEX MIJ SOMATEX MEDICAL TECHNOLOGIES GMBH 271641 51269 04250195611574

    Patients

    Seq Age Sex Outcome Treatment
    1