BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 17762162 · Received September 16, 2023

    Report

    Report Number
    8043817-2023-00011
    Event Type
    Malfunction
    Date Received
    September 16, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 16, 2023
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    PUI
    UDI-DI
    00748426092437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICROSCOPE DRAPE WAS OPENED TO THE FIELD. AS SCRUB TECH WAS PICKING UP SUPPLIES AND ORGANIZING SHE FOUND A HAIR STUCK INSIDE THE MICROSCOPE DRAPE. THIS WAS IMMEDIATELY REMOVED AND OPERATING ROOM TEAM BROKE DOWN THE STERILE FIELD BECAUSE OF POSSIBLE CONTAMINATION. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332345 MICROTEK MICROSCOPE DRAPE PUI MICROTEK DOMINICANA, S.A. AR8033650 1442LR1200 00748426092437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown