BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT HEEL INCISION DEVICE

    MDR report key: 4239929 · Received October 29, 2014

    Report

    Report Number
    2250033-2014-00007
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 17, 2013
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED 10/28/2014 REFERS TO ITC COMPLAINT CASE (B)(4). RETROSPECTIVE ANALYSIS OF COMPLAINT RECORDS WHERE THE TENDERFOOT IDENTIFIED THIS CASE FOR REPORTABILITY. NO NCMRS WERE IDENTIFIED FOR THE DEVICE. NO RELATED COMPLAINT TRENDS IDENTIFIED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT THE TENDERFOOT DEVICE CAME APART PRIOR TO USE AND WAS NOT USED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693099 TENDERFOOT HEEL INCISION DEVICE JCA INTERNATIONAL TECHNIDYNE CORP. TF1000I BH336M

    Patients

    Seq Age Sex Outcome Treatment
    1