BEUDAMED
    FDA Adverse Event Summary report: N

    NUPREP

    MDR report key: 4023147 · Received April 8, 2014

    Report

    Report Number
    4023147
    Date Received
    April 8, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 8, 2014
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD EEG PREVIOUS DAY. NUPREP AND TEN20 WERE USED DURING THE EEG. ORDER FOR EEG LEADS TO BE REMOVED TODAY. POST REMOVAL OF LEADS, TWO PINK TEARDROP AREAS NOTED TO FOREHEAD. APPROXIMATELY ONE HOUR LATER, THE AREAS SEEMED LARGER AND PINKER, ESPECIALLY ON THE RIGHT SIDE WHICH APPEARED EDEMATOUS AND SLIGHTLY ABRADED TO CENTER. THE AREA CONTINUED TO GET SLIGHTLY LARGER AND PUFFIER OVER THE NEXT HOUR. MDS ALERTED AND SKIN TEAM CONSULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211966 NUPREP ELECTRODE, ELECTROCARDIOGRAPH GYB D.O. WEAVER AND COMPANY * *
    212341 TEN20 MEDIA, ELECTROCONDUCTIVE GYB D.O. WEAVER AND COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR EKG LEAD, PULSE OXIMETER, BP CUFF, TRACHEOSTOMY| TUBE, EEG LEADS.