BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11632067 · Received April 7, 2021

    Report

    Report Number
    3011610434-2021-00004
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Report Date
    April 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 (B)(6) 2021 OF A REPORT FROM (B)(6) HOSPITAL 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 17-MAR-2021. THE FRACTURE ON THE TIP WAS CONFIRMED. INNOVATIVE HEALTH CONTACTED THE HEALTHCARE FACILITY IN TWO DIFFERENT OCCASIONS ON (B)(6) 2021 AND (B)(6) 2021 TO OBTAIN ADDITIONAL DETAILS ABOUT THE INCIDENT. NO ADDITIONAL DETAILS WERE PROVIDED. PATIENT WAS NOT INJURED.

    Description of Event or Problem · 1

    THE CATHETER TIP OF VIEWFLEX XTRA ICE DEVICE REPORTEDLY BROKE IN THE PATIENT DURING THE CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529597 N/A DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1