BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-MEDIC BEYER RONGEUR, 7" CURVED, 3X14MM BITE

    MDR report key: 2092915 · Received April 11, 2011

    Report

    Report Number
    3005236665-2011-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 22, 2011
    Manufacturer
    TELEFLEX MEDICAL TUTTLINGEN GMBH
    Product Code
    HAE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DEVICE HAD A FRACTURED JAW. THE DEFECT WAS DISCOVERED DURING AN OPERATION ON A PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-MEDIC BEYER RONGEUR, 7" CURVED, 3X14MM BITE RONGEUR HAE TELEFLEX MEDICAL TUTTLINGEN GMBH NA RR9

    Patients

    Seq Age Sex Outcome Treatment
    1