BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULONG NANOLINE

    MDR report key: 7098952 · Received December 8, 2017

    Report

    Report Number
    9611612-2017-00017
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 12, 2017
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K043130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ITEM NUMBER AND MANUFACTURING LOT CAN NEITHER BE IDENTIFIED NOR RECONSTRUCTED. BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.

    Additional Manufacturer Narrative · 1

    CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN SENT BACK/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Description of Event or Problem · 1

    IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: STIMULATION WIRE CAME OUT OF CATHETER TUBE.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORTER´S NARRATIVE: STIMULATION WIRE CAME OUT OF CATHETER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879102 STIMULONG NANOLINE CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE NOT AVAILABLE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R