BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH PRODUCTS LLC

    MDR report key: 7542305 · Received May 24, 2018

    Report

    Report Number
    2025917-2018-00106
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 24, 2018
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    DRX
    UDI-DI
    00812594010293
    PMA / PMN Number
    K011564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CIRCULAR RASH WITH BLISTERS WAS NOTICED ON PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383213 NEOTECH PRODUCTS LLC RADIOLUCENT NEOLEADS DRX NEOTECH PRODUCTS LLC N305 2017-9012 00812594010293

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Other