BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT 50PK DEVICES

    MDR report key: 2068117 · Received March 31, 2011

    Report

    Report Number
    2250033-2011-00007
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 15, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. NO OTHER COMPLAINTS WERE RECEIVED FOR THIS LOT. A SEARCH OF COMPLAINTS FOR THE PAST 2 YEARS INDICATES NO OTHER CASES OF FAILURE TO RETRACT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS USER INJURY USING TENDERFOOT 50PK DEVICE. CUSTOMER REPORTED THAT A NURSE WAS USING THE DEVICE TO INCISE A PT. SHE PUT THE DEVICE DOWN ON THE COUNTER EXPECTING THE BLADE TO HAVE RETRACTED. CLEANING UP AFTERWARDS, SHE PICKED UP THE DEVICE AND CUT HER RIGHT THUMB. THE CUT WAS TREATED USING STANDARD NEEDLESTICK PROTOCOL FOR THE SITE. THE CUT WAS WASHED OUT AND WIPED WITH ALCOHOL. NO ADVERSE EVENT (S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDERFOOT 50PK DEVICES JCA INTERNATIONAL TECHNIDYNE CORPORATION TF501 BN036

    Patients

    Seq Age Sex Outcome Treatment
    1