BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 15829528 · Received November 18, 2022

    Report

    Report Number
    3011610434-2022-00014
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    November 18, 2022
    Manufacturer
    INNOVATIVE HEALTH, LLC
    Product Code
    NLH
    UDI-DI
    10841898123290
    PMA / PMN Number
    K203655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH, LLC BECAME AWARE ON 20-OCT-2022 OF A DEVICE IN MAYO CLINIC - (B)(4) THAT WAS PLACED IN A COMPLAINT BIN. THE DEVICE WAS A WEBSTER CS BI-DIRECTIONAL DIAGNOSTIC EP CATHETER AUTO ID. MULTIPLE FOLLOW-UPS WERE MADE TO ACQUIRE INFORMATION ABOUT THE EVENT; HOWEVER, NO INFORMATION WAS ABLE TO BE PROVIDED. IT IS UNKNOWN WHEN THE ISSUE OCCURRED AND WHEN IT WAS IDENTIFIED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 24-OCT-2022. UPON INVESTIGATION, FOREIGN MATERIAL WAS IDENTIFIED ON THE TIP OF THE DEVICE. NO INJURY WAS REPORTED. PRODUCTION RECORDS WERE ALSO REVIEWED. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 0

    THIS DEVICE WAS IDENTIFIED IN A COMPLAINT BIN AT THE CUSTOMER SITE BY AN INNOVATIVE HEALTH EMPLOYEE. NO INFORMATION WAS PROVIDED REGARDING THE EVENT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED AND WHEN IT WAS IDENTIFIED. UPON INSPECTING THE COMPLAINT DEVICE, FOREIGN MATERIAL WAS IDENTIFIED ON THE TIP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464937 NA DIAGNOSTIC EP CATHETER AUTO ID NLH INNOVATIVE HEALTH, LLC BD710DF282CT 10841898123290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown