BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH PRODUCTS LLC

    MDR report key: 7538092 · Received May 23, 2018

    Report

    Report Number
    2025917-2018-00103
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 23, 2018
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    DRX
    PMA / PMN Number
    K011564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT REPORTED BEING SENSITIVE TO ALL ADHESIVES AND CIRCULAR RASH/BURN WITH WHITE PAPULES/BLISTERS WAS NOTICED ON HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379714 NEOTECH PRODUCTS LLC RADIOLUCENT NEOLEADS DRX NEOTECH PRODUCTS LLC N305 2017-9011

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other