BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT DEVICE 1000/CS

    MDR report key: 2337025 · Received November 1, 2011

    Report

    Report Number
    2250033-2011-00028
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Report Date
    October 4, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT - NO OTHER COMPLAINTS RECEIVED FOR THIS LOT. A SEARCH OF COMPLAINTS FOR THE PAST 1 YEAR INDICATED NO OTHER CASES OF FAILURE TO RETRACT. CONCLUSION - DEVICE EXPECTED TO RETURN TO ITC FOR EVAL. EVAL OF RETAIN SAMPLES FOR SAME LOT PERFORMED ACCORDING TO SPECS.

    Description of Event or Problem · 1

    ITC SALES REP REPORTS THAT THE DEMO KIT BLADE ON HER TENDERFOOT DEVICE DID NOT FULLY RETRACT. NO REPORT OF INJURY. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDERFOOT DEVICE 1000/CS JCA INTERNATIONAL TECHNIDYNE CORP. TF1000I BH007

    Patients

    Seq Age Sex Outcome Treatment
    1