BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11803474 · Received May 10, 2021

    Report

    Report Number
    3011610434-2021-00009
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 7, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K173262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE ON 09-APR-2021 OF A REPORT FROM (B)(6) 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 12-APR-2021. THE FRACTURE ON THE TIP WAS CONFIRMED. INNOVATIVE HEALTH CONTACTED THE HEALTHCARE FACILITY ON 12-APR-2021 AND 16-APR-2021 TO OBTAIN ADDITIONAL DETAILS ABOUT THE INCIDENT REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED. THE PATIENT WAS NOT INJURED.

    Description of Event or Problem · 1

    THE TIP OF A VIEWFLEX XTRA ICE CATHETER WAS REPORTED TO BREAK DURING A PROCEDURE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699549 N/A ULTRASOUND DIAGNOSTIC CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1