BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 6043656 · Received October 20, 2016

    Report

    Report Number
    6043656
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    February 22, 2016
    Report Date
    June 3, 2016
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE CASE, IT WAS DISCOVERED THAT THE SLUSH DRAPE HAD A TEAR IN THE WARMER SIDE. THE SURGICAL TECH WAS REMOVING THE USED DRAPE AND FLUID WAS FOUND TO BE LEAKING. (B)(4)WAS INFORMED. TEAR WAS IN THE STERILE DRAPE SLUSH 52X66 LOT#1053464. THE PATIENT WILL BE FOLLOWED BY INFECTION PREVENTION FOR 90 DAYS FOR INFECTION. MANUFACTURER IS MEDICAL ACTION INDUSTRIES (B)(4). SLUSH DRAPE IDENTIFIED AS (B)(4), LOT #1053464.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696834 MICROTEK DRAPE, SURGICAL KKX MICROTEK MEDICAL, INC. 52 X 66 1053464

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR