BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPREP GEL

    MDR report key: 1617127 · Received February 22, 2010

    Report

    Report Number
    1718791-2010-00001
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    August 21, 2009
    Report Date
    February 22, 2010
    Manufacturer
    D.O. WEAVER AND CO.
    Product Code
    GYB
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUSSED INCIDENT WITH FEMALE PT AND WITH CAREGIVER. FEMALE PT HAS HAD SOME HAIR GROW BACK BUT NOT COMPLETE. SHE IS ON MEDICATIONS THAT HAVE HAD IMPLICATIONS IN HAIR LOSS, BUT IS RARE. FEMALE PT IS SEEKING FINANCIAL COMPENSATION BUT HAS NOT FILED A LAWSUIT AGAINST US OR AGAINST THE CAREGIVER.

    Description of Event or Problem · 1

    PATIENT HAD SLEEP STUDY DONE AT (B)(6) BY TECHNOLOGIST ON (B)(6), 2009. AFTER SLEEP STUDY AND AT HOME, PATIENT WASHED HER HAIR AND LATER NOTICED WHERE ELECTRODES WERE PLACED, SHE HAD HAIR LOSS. THIS OCCURRED IN TWO ELECTRODES SITES AT THE BACK OF THE HEAD. FEMALE PT WENT TO A DERMATOLOGIST ON (B)(6) 2009 AND HAS RECEIVED STEROID SHOTS TO STIMULATE HAIR GROWTH. THIS HAS BEEN MET WITH SOME SUCCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other TEN20 CONDUCTIVE PASTE ((B)(6) 2009)