BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOUFFANT CAPS PRO SERIES

    MDR report key: 5055972 · Received September 4, 2015

    Report

    Report Number
    5055972
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 7, 2015
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    FYF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NEW BOX OF BOUFFANT CAPS WAS OPENED. UPON OPENING THE INTACT BOX, A PAIR OF FINGERLESS GLOVES WERE FOUND INSIDE THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588361 BOUFFANT CAPS PRO SERIES CAP, SURGICAL FYF MEDLINE INDUSTRIES 54214121119

    Patients

    Seq Age Sex Outcome Treatment
    1