BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12700995 · Received October 26, 2021

    Report

    Report Number
    3011610434-2021-00017
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 26, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K202042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE ON 08-OCT-2021 OF A REPORT FROM (B)(6) HOSPITAL ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A BROKEN TIP WHILE IN USE DURING A PROCEDURE. NO PATIENT INJURIES WERE REPORTED. ADDITIONAL FEEDBACK FROM THE HOSPITAL WAS UNAVAILABLE. UPON RECEIPT OF THE DEVICE, THE DISTAL TIP WAS CONFIRMED TO BE BROKEN. THE FRACTURED TIP REMAINED ATTACHED TO THE DEVICE. NO FURTHER DAMAGE WAS IDENTIFIED ON THE DEVICE.

    Description of Event or Problem · 1

    THE TIP OF THIS DEVICE WAS REPORTED TO BE BROKEN DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598451 NA DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1