BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 2471338 · Received February 22, 2012

    Report

    Report Number
    2471338
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    November 29, 2011
    Report Date
    February 7, 2012
    Manufacturer
    D. O. WEAVER AND COMPANY
    Product Code
    GYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WROTE COMPLAINT LETTER TO THE HOSPITAL STATING THAT SHE HAD EXPERIENCED SIGNIFICANT HAIR LOSS WHERE THE EEG ELECTRODES HAD BEEN GLUED TO HER HEAD (ON THE SEIZURE MONITORING UNIT). PATIENT HAD BEEN HOSPITALIZED FOR 8 DAYS AND NOTED THE HAIR LOSS AFTER SHE WAS HOME FROM THE HOSPITAL. PATIENT ALSO E-MAILED SEVERAL PICTURES OF THE BALD SPOTS ON HER HEAD (WHERE ELECTRODES HAD BEEN GLUED). PATIENTS SIGN A FORM DESCRIBING THE RISKS OF EPLIEPSY MONITORING, WHICH SPECIFICALLY STATES THAT "...SMALL PATCHES OF HAIR ARE SOMETIMES LOST." HOWEVER, THE PATIENT'S PICTURES SHOW MORE THAN SMALL PATCHES OF HAIR WERE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN20 CONDUCTIVE PASTE CONDUCTIVE PASTE, EEG MONITORING GYB D. O. WEAVER AND COMPANY * *
    2 COLLODION USP COLLODIAN, USP GYB MAVIDON MEDICAL PRODUCTS * *
    3 MAVIDON ADHESIVE REMOVER, MEDICAL GYB MAVIDON MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR