BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP GEL

    MDR report key: 1818842 · Received August 24, 2010

    Report

    Report Number
    1718791-2010-00005
    Event Type
    Other
    Date Received
    August 24, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 25, 2010
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT NOT SEEN BY REPORTER AFTER DATE OF INITIAL TEST. INFO DESCRIBING INJURY WAS REPORTED TO HER BY NEUROLOGIST.

    Description of Event or Problem · 1

    PT HAD AN EEG EXAMINATION ON (B)(6) 2010. NO SIGN OF INJURY BY TECHNICIAN AT THE TIME OF THE TEST. PT REPORTED TO NEUROLOGIST 6 WEEKS AFTER INITIAL EXAM AND PRESENTED WITH HAIR LOSS AND SOME BLEEDING AT ELECTRODE SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL ABRASIVE SKIN PREP GEL GYB D.O. WEAVER AND COMPANY 10-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other TEN20 CONDUCUTIVE PASTE| DATE OF TX 2010)