BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 12700917 · Received October 26, 2021

    Report

    Report Number
    3011610434-2021-00018
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 8, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE ON (B)(6) 2021 OF A REPORT FROM (B)(6) OF (B)(6) ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE WHILE IN USE DURING A PROCEDURE. PER THE FEEDBACK RECEIVED FROM THE HOSPITAL, THIS DEVICE WAS REPORTED TO HAVE BEEN INSIDE THE PATIENT WHEN THE TIP FRACTURED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2021. UPON INVESTIGATION, THE FRACTURE ON THE DEVICE WAS CONFIRMED. THE TIP DID NOT FALL OFF COMPLETELY AND WAS ATTACHED TO THE SHAFT. NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE TIP OF THIS DEVICE WAS REPORTED TO HAVE BROKEN WHILE INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597824 NA DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1