BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11713334 · Received April 23, 2021

    Report

    Report Number
    3011610434-2021-00005
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 22, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K173262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE OF AN INCIDENT WITH A VIEWFLEX XTRA ICE DEVICE ON 23-MAR-2021. IT WAS CONFIRMED THAT THE DISTAL TIP PARTIALLY BROKE WHILE IN USE, THE DOCTOR WAS ABLE TO RETRIEVE THE ENTIRE CATHETER WITHOUT ANY EXTRA INTERVENTION. THE DEVICE WAS RETURNED FOR EVALUATION ON 16-APR-2021. A FOLLOW UP WAS CONDUCTED ON (B)(6) 2021, WITH THE HEALTHCARE FACILITY AND THE DETAILS OF THE CASE WERE CONFIRMED AS PREVIOUSLY REPORTED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    A VIEWFLEX XTRA ICE DEVICE WAS REPORTED TO BE IN USE INSIDE THE PATIENT WHEN THE DISTAL TIP BROKE. THE TIP DID NOT FALL OFF COMPLETELY, AND THE ENTIRE CATHETER WAS ABLE TO BE RETRIEVED WITHOUT ANY ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615033 N/A DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1