BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 13061047 · Received December 22, 2021

    Report

    Report Number
    8043817-2021-00012
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 22, 2021
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE FOUND IN THE MICROSCOPE DRAPE. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965902 OLYMPUS MICROSCOPE DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. OME-V2-D NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown