BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVII

    MDR report key: 6854498 · Received September 11, 2017

    Report

    Report Number
    6854498
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 26, 2017
    Report Date
    August 30, 2017
    Manufacturer
    MONICA HEALTHCARE LIMITED
    Product Code
    OSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS USING THE MONICA NOVII DEVICE FOR FETAL MONITORING. WHEN THE PATCHES WERE REMOVED, THERE WAS AN OPEN AND ABRADED AREA UNDER EACH OF THE FOUR PATCHES ON THE PATIENT'S ABDOMEN. TWO OF THE AREAS WERE WEEPING AND REQUIRED A DRESSING. THE WOUNDS WERE APPROXIMATELY 3 CM X 3 CM EACH. SCRATCH MARKS WERE VISIBLE FROM THE USE OF THE 3M RED DOT TRACE PREP, WHICH WAS USED PRIOR TO PATCH PLACEMENT. THE PEEL AND STICK PADS WERE ADHERED AROUND 10:30 A.M. AND REMOVED AROUND 10 P.M. IN FOLLOW UP, THE NURSE MANAGER REVIEWED THE NOVII PATCH INSTRUCTIONS, WHICH INDICATES TO INFORM THE PATIENT THAT THE PATCH MAY CAUSE SKIN IRRITATION AND TO REPORT ANY PAIN OR BURNING AT THE SKIN SITE WHERE THE PATCH IS USED. THIS INFORMATION WAS DISCUSSED WITH THE TEAM MEMBERS INVOLVED AND THIS PROCESS WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636407 NOVII UTERINE ELECTROMYOGRAPHIC MONITOR OSP MONICA HEALTHCARE LIMITED 107-PT-004

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other 3M RED DOT TRACE PREP (2236) PART NO, 100-PT-007 U