BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALIST 100 COTTON STERILE CAST PADDING

    MDR report key: 6739679 · Received July 25, 2017

    Report

    Report Number
    6739679
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    June 27, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    ITG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE OPERATING ROOM (O.R), THE STERILE PACKAGING FOR THE PRODUCT LISTED WAS OPENED ONTO A STERILE FIELD. AFTER OPENING THE PACKAGING, AN INSECT (IDENTIFIED BY STAFF AS A MOSQUITO) WAS FOUND IN THE PADDING MATERIAL OF THE PRODUCT. THE ITEM WAS REMOVED FROM THE O.R AND THE STERILE FIELD WAS TAKEN DOWN AND A NEW FIELD SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521515 SPECIALIST 100 COTTON STERILE CAST PADDING BANDAGE, CAST ITG BSN MEDICAL, INC. 9086S 357670

    Patients

    Seq Age Sex Outcome Treatment
    1