BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCI- TUMESCENT CATHETER INVERSION SYSTEM

    MDR report key: 818921 · Received January 30, 2007

    Report

    Report Number
    1216828-2007-00002
    Event Type
    Malfunction
    Date Received
    January 30, 2007
    Date of Event
    January 3, 2007
    Report Date
    January 29, 2007
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    GAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION; THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE PERFORATED TUBING PULLED OUT OF THE GREEN ATTACHMENT CAUSING 6" OF VEIN NOT TO BE STRIPPED. SALES REP. STATED THAT A HEMATOMA WAS PRESENT, BUT THE DOCTOR WAS NOT CONCERNED ABOUT IT. IT WAS INDICATED THAT THE HEMATOMA SHOULD CLEAR UP AND THERE WAS NO NEED FOR FOLLOW-UP. THERE WAS NO INJURY REPORTED AND THE PT WILL NOT BE HAVING SURGERY TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCI- TUMESCENT CATHETER INVERSION SYSTEM * GAJ SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7210023 60847153

    Patients

    Seq Age Sex Outcome Treatment
    1 YR