BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT

    MDR report key: 777644 · Received October 31, 2006

    Report

    Report Number
    2430952-2006-00043
    Event Type
    Malfunction
    Date Received
    October 31, 2006
    Report Date
    October 26, 2006
    Manufacturer
    KOROS USA, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE IS SLIPPING. NO PATIENT CONTACT HAS BEEN REPORTED. ACCORDING TO THE USER FACILITY, THE REPORTED EVENT WAS NOT THE FIRST TIME THE PRODUCT HAD BEEN USED. THE ITEM HAD BEEN PURCHASED AS PART OF A RETRACTOR SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT JARITRAK RETRACTOR SYSTEM GAD KOROS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *