BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAJUNK TSUI STIMULONG EPIDURAL CATHETER

    MDR report key: 2442381 · Received February 1, 2012

    Report

    Report Number
    MW5024132
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    PAJUNK MEDIZINTECHNOLOGIE
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PAJUNK TSUI STIMULONG EPIDURAL CATHETER: AFTER PLACEMENT AND AFTER STYLET WAS REMOVED, WIRE REINFORCING COIL AND STIMULATING WIRE OF THE CATHETER DISLODGED. IN A SECOND INSTANT, ONLY THE STIMULATING WIRE DISLODGED AFTER THE STYLET WAS REMOVED. DEVICE 1: DATES OF USE: (B)(6) 2011-(B)(6) 2011. DEVICE 2: (B)(6) 2011-(B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAJUNK TSUI STIMULONG EPIDURAL CATHETER PAJUNK TSUI STIMULONG EPIDURAL CATHETER 20 G GCB PAJUNK MEDIZINTECHNOLOGIE 916
    2 PAJUNK TSUI STIMULONG EPIDURAL CATHETER PAJUNK TSUI STIMULONG EPIDURAL CATHETER 20G GCB PAJUNK MEDIZINTECHNOLOGIE 916

    Patients

    Seq Age Sex Outcome Treatment
    1