BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 16808934 · Received April 25, 2023

    Report

    Report Number
    3011610434-2023-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    January 1, 2023
    Report Date
    December 19, 2023
    Manufacturer
    INNOVATIVE HEALTH, LLC
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K202042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE THAT THE ORIGINAL SUBMISSION CONTAINED AN ERRONEOUS SELECTION ON THE "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" FIELD. NO PATIENT INJURIES WERE REPORTED ASSOCIATED WITH THIS EVENT AND NO APPARENT HARM OCCURRED IN RELATION TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE ON (B)(6) 2023 OF A VIEWFLEX XTRA ICE DEVICE FROM PROVIDENCE ST VINCENT MEDICAL CENTER REPORTED TO HAVE A "BENT TIP, NO SIGNAL". INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2023. UPON INVESTIGATION, THE FRACTURE ON THE DEVICE WAS CONFIRMED. THE TIP DID NOT FALL OFF COMPLETELY AND WAS ATTACHED TO THE SHAFT. THE FRACTURED TIP LIKELY CONTRIBUTED TO THE NO SIGNAL REPORTED. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WAS REPORTED TO HAVE A BENT TIP AND NO SIGNAL. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186276 N/A DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention