BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT DEVICES 50/PKM

    MDR report key: 1774703 · Received July 26, 2010

    Report

    Report Number
    2250033-2010-00010
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 26, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHILE THE NURSE WAS ADMINISTERING A HEEL STICK ON THE PATIENT WITH TENDERLETT DEVICE, DEVICE SPLIT OPEN AND THE LANCE CAME OUT THE SIDE INSTEAD OF THE BOTTOM OF THE DEVICE. NO INJURY REPORTED TO NURSE OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDERFOOT DEVICES 50/PKM NEWBORN HEEL INCISION DEVICE JCA INTERNATIONAL TECHNIDYNE CORPORATION TF501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1