BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECO LAB MICROTEK MEDICAL INC.

    MDR report key: 8032940 · Received November 1, 2018

    Report

    Report Number
    MW5081015
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ECO LAB / MICROTEK MEDICAL INC.
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WARMER DRAPE USED FOR IRRIGATION FLUID. AT END OF CASE WHEN DRAPE REMOVED, DISCOVERED FLUID IN THE WARMER PAN. THE WARMER DRAPE HAD A HOLE AND THERE WAS COMMUNICATION BETWEEN THE UNSTERILE METAL RECEPTACLE AND THE IRRIGATION FLUID. THE PRODUCT IS NOT COMPOUNDED; THE PRODUCT IS NOT OVER-THE-COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867441 ECO LAB MICROTEK MEDICAL INC. ECO LAB, MICROTEK MEDICAL INC, WARMER, IRRIGATION, SOLUTION LHC ECO LAB / MICROTEK MEDICAL INC. D180969

    Patients

    Seq Age Sex Outcome Treatment
    0 Required Intervention