BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP GEL

    MDR report key: 480665 · Received August 26, 2003

    Report

    Report Number
    1718791-2003-00004
    Event Type
    Injury
    Date Received
    August 26, 2003
    Date of Event
    February 1, 2003
    Report Date
    August 26, 2003
    Manufacturer
    D.O. WEAVER & CO.
    Product Code
    GYB
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS HAD AN AMBULATORY EEG (24 HOURS) IN FEB. THERE WAS A SECOND PATIENT WITH LESS INJURY. THESE TWO PATIENTS HAD A DARK AREA AT THE SITE OF T5 AND AT F2 (BY THE EAR AND CENTER FRONT.) THEY CLAIMED TO HAVE FELT SOMETHING LIKE AN ELECTRICAL TINGLE. BIOMEDICAL DEPARTMENT CHECKED OUT THE EQUIPMENT AND THEN SENT THE EQUIPMENT BACK TO BIOLOGIC FOR EVALUATION. NEITHER BIOMED DEPT AT THE HOSPITAL NOR BIOLOGIC COULD FIND A PROBLEM. DEVICE RETURNED BY BIOLOGIC. THAT IS WHEN IT HAPPENED AGAIN. THEY HAVE DISCONTINUED THE PROCEDURE AT THE HOSPITAL. THEY USED NUPREP AND TEN20 ON THESE PATIENTS AS WELL AS MANY OTHERS. PATIENT 1 HAD PLASTIC SURGERY TO REPAIR A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL ABRASIVE GEL GYB D.O. WEAVER & CO. 10-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention BIOLOGIC MONITOR (2003).| TEN20 CONDUCTIVE PASTE (2003),