BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING HEISS RETRACTOR, 4X4

    MDR report key: 1970883 · Received January 4, 2011

    Report

    Report Number
    1044475-2011-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GZT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE RETRACTOR BROKE CLOSE TO THE JOINT. THIS HAPPENED WHEN THE TECHNICIAN OPENED AND CLOSED THE RETRACTOR BEFORE IT WAS USED ON THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING HEISS RETRACTOR, 4X4 SELF-RETAINING RETRACTOR GZT TELEFLEX MEDICAL NA MM8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK