BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 13096687 · Received December 28, 2021

    Report

    Report Number
    8043817-2021-00013
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    UDI-DI
    50748426091664
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN THE INTERIOR OF THE MICROSCOPE DRAPE PACKAGE WHILE SETTING UP THE DRAPE. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991016 MICROTEK ARMATEC MICROSCOPE DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. AR8033654 D203142 50748426091664

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown