BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 8577310 · Received May 3, 2019

    Report

    Report Number
    8577310
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 16, 2019
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    KKX
    UDI-DI
    00748426011742
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    APPEARS TO BE MANUFACTURING DEFECT IN PLACEMENT OF INSTRUCTIONAL DIAGRAM FOR STERILE APPLICATION. ECOLAB MICROTEK SHOULDER ARTHROSCOPY DRAPE REF #(B)(4), LOT #D183304 WAS DESIGNED SO THAT WHEN YOU DRAPE THE LOWER PART OF THE BODY, THE ADHESIVE PART OF THE DRAPE IS ON THE WRONG SIDE. IF YOU USE THE DIAGRAM ON THE DRAPE - YOU ARE PLACING UPSIDE DOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369951 MICROTEK DRAPE, SURGICAL KKX MICROTEK MEDICAL, INC. 1 D183304 00748426011742

    Patients

    Seq Age Sex Outcome Treatment
    1