BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLED PROBE COVER

    MDR report key: 12432222 · Received September 7, 2021

    Report

    Report Number
    12432222
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 27, 2021
    Manufacturer
    MICROTEK MEDICAL B.V.
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROLLED ECOLAB MICROTEK PROBE COVER TIP SHREDDED WHEN REMOVED FROM PACKAGING AND ATTEMPTED TO APPLY COVER TO PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332911 ROLLED PROBE COVER TRANSDUCER, ULTRASONIC JOP MICROTEK MEDICAL B.V. PC0906NS D181691

    Patients

    Seq Age Sex Outcome Treatment
    1