BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 12806722 · Received November 12, 2021

    Report

    Report Number
    8043817-2021-00006
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    UDI-DI
    50748426107372
    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, WHICH WAS SPOTTED AT THE OPENING OF THE COVER. NO PATIENT INFECTION OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701177 MICROTEK MEDICAL INC. PROBE COVER PUI ECOLAB/MICROTEK MEDICAL INC. APC1290 D210551 50748426107372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown