BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 12839844 · Received November 18, 2021

    Report

    Report Number
    3006116468-2021-00001
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    May 5, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    UDI-DI
    50748426090209
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A TEAR IN THE PROBE COVER. NO PATIENT INJURY OR INFECTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738814 MICROTEK MEDICAL INC. PROBE COVER PUI ECOLAB/MICROTEK MEDICAL INC. GPC396EU D201271 50748426090209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown