BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 14500507 · Received May 25, 2022

    Report

    Report Number
    3011610434-2022-00007
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 1, 2022
    Report Date
    May 23, 2022
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K202042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE ON (B)(6) 2022 OF A REPORT FROM (B)(6) HOSPITAL ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A BEND ON THE DISTAL SHAFT WHILE INSIDE THE PATIENT. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 11-MAY-2022. UPON INVESTIGATION, THE BEND ON THE DISTAL SHAFT OF THE DEVICE WAS CONFIRMED. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE DISTAL SHAFT OF THIS DEVICE WAS REPORTED TO HAVE BENT WHILE INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815542 NA DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown