BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE

    MDR report key: 4373496 · Received December 22, 2014

    Report

    Report Number
    3006680097-2014-00008
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Report Date
    December 22, 2014
    Manufacturer
    THD SPA-CORREGGIO(RE)
    Product Code
    JAF
    PMA / PMN Number
    K081429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO (B)(4). ADDITIONAL INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THD DOPPLER PROBE HAD A CONNECTION PROBLEM WITH THD MACHINE SYSTEM. ANOTHER DOPPLER PROBE WAS OPENED TO COMPLETE THE TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843633 THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE DOPPLER PROBE NON STERILE JAF THD SPA-CORREGGIO(RE) 800056B NA

    Patients

    Seq Age Sex Outcome Treatment
    1