BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPR SDE CTG CARB BUR

    MDR report key: 118444 · Received September 3, 1997

    Report

    Report Number
    1811755-1997-00075
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Report Date
    August 12, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PER CUSTOMER, BROKE TWO BURS. THERE WAS NO INJURY AND IT WAS DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPR SDE CTG CARB BUR BUR EJL STRYKER INSTRUMENTS 1607-002-109 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN