BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TUBE

    MDR report key: 1084880 · Received July 30, 2008

    Report

    Report Number
    MW5007855
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 30, 2008
    Manufacturer
    MOSS TUBE INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    J-TUBE WAS FOUND OUT OF PT. TUBE HAD TO BE REPLACED. PHYSICIAN REQUESTED REPORT TO BE COMPLETED. PER OR STAFF, THIS IS THE 2ND EVENT IN WHICH A J-TUBE DISLODGED FOR UNKNOWN REASON. DATES OF USE: 2008, 24 HOURS. DIAGNOSIS OR REASON FOR USE: SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TUBE J-TUBE KNT MOSS TUBE INC 16365

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR