BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESMARK

    MDR report key: 5317886 · Received December 22, 2015

    Report

    Report Number
    5317886
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 14, 2015
    Report Date
    December 15, 2015
    Manufacturer
    AVCOR HEALTHCARE PRODUCTS INC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I OPENED AN ESMARK BAND ONTO THE STERILE FIELD AND IT HAD A LONG BLACK HAIR WRAPPED AROUND IT. MANUFACTURER RESPONSE FOR X-MARK - LATEX-FREE ESMARK BANDAGE 6''W X 3 YDS L, X-MARK (PER SITE REPORTER): THEY GAVE ME THEIR EMAIL ADDRESS AND TOLD ME TO EMAIL THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844179 ESMARK BANDAGE, ELASTIC FQM AVCOR HEALTHCARE PRODUCTS INC. 23578-163 101214

    Patients

    Seq Age Sex Outcome Treatment
    1