BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING CHEANVECHAI SWIVEL RAKE RET

    MDR report key: 3072657 · Received April 19, 2013

    Report

    Report Number
    1044475-2013-00045
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: "CUSTOMER CALLED TO REPORT THAT DURING A PROCEDURE, WHEN THE NUT TIGHTENED THE DEVICE IT CRACKED AND THE NUT CAME OFF. THE NUT WAS RETRIEVED AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION." PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170386 PILLING CHEANVECHAI SWIVEL RAKE RET RETRACTOR GAD TELEFLEX LO

    Patients

    Seq Age Sex Outcome Treatment
    1