BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLEY CLAMP

    MDR report key: 1762950 · Received June 30, 2010

    Report

    Report Number
    1044475-2010-00065
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 7, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE HAS NOT BEEN RECEIVED AT THIS TIME. THE RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS DESCRIBED AS: JAW OF DEVICE CRACKED. FOUND ON INCOMING INSPECTION PRIOR TO USE ON A PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLEY CLAMP CLAMP GDJ TELEFLEX MEDICAL NA MM9

    Patients

    Seq Age Sex Outcome Treatment
    1