BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE ADVANTAGE

    MDR report key: 552166 · Received August 31, 2004

    Report

    Report Number
    MW1033511
    Event Type
    Malfunction
    Date Received
    August 31, 2004
    Date of Event
    August 11, 2004
    Report Date
    August 11, 2004
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE REMOVED GLOVE AFTER PERFORMING PELVIC EXAM ON PT HAVING THEIR MENSTRUAL CYCLE. SHE OBSERVED BLOOD ON ONE OF HER FINGERS. EXAMINATION OF GLOVES REVEALED GLOVES TO HAVE AREAS TO BE THINNER WHERE THE PURPLE COLOR WAS NOT EVENLY DISTRIBUTED - A TIE DYED LOOKING EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE ADVANTAGE NON-LATEX PURPLE NITRILE EXAM GLOVES FMC TILLOTSON HEALTHCARE CORP. REF 02-6502 D1A30092

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other