BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 3866474 · Received April 24, 2014

    Report

    Report Number
    3006697299-2014-00025
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    C3601 CUSA EXCEL 36KHZ TUBING SET HAD A HAIR FOUND IN THE SEALED PACKAGE. THE HAIR WAS DISCOVERED DURING INCOMING INSPECTION BY THE DISTRIBUTOR. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249014 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA LIFESCIENCES IRELAND LIMITED 1132943

    Patients

    Seq Age Sex Outcome Treatment
    1