BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11845727 · Received May 18, 2021

    Report

    Report Number
    3011610434-2021-00011
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 17, 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 ON (B)(6) 2021 OF A REPORT FROM (B)(6) CENTER ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE WHILE THE DEVICE WAS IN USE DURING A PROCEDURE. INNOVATIVE HEALTH RECEIVED THE DEVICE BACK ON (B)(6) 2021. THE FRACTURE ON THE TIP WAS CONFIRMED. INNOVATIVE HEALTH CONFIRMED ON (B)(6) 2021 THE DETAILS OF THE OCCURRENCE. THE PATIENT WAS NOT INJURED.

    Description of Event or Problem · 1

    THIS DEVICE WAS REPORTED TO BE IN USE INSIDE THE PATIENT WHEN THE DISTAL TIP BROKE. THE TIP DID NOT DETACH FROM THE SHAFT, AND THE DOCTOR WAS ABLE TO RETRIEVE THE ENTIRE CATHETER WITHOUT ANY EXTRA INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740818 N/A DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1