BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONICA NOVII WIRELESS PATCH SYSTEM

    MDR report key: 9309369 · Received November 12, 2019

    Report

    Report Number
    3006340424-2019-00002
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 5, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MONICA HEALTHCARE LTD
    Product Code
    OSP
    PMA / PMN Number
    K140862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REVIEWED BY GE HEALTHCARE MEDICAL DIRECTOR. THE NOVII PATCHES DO NOT EMIT HEAT AND THERE WAS NO MALFUNCTION THUS A BURN REACTION IS NOT POSSIBLE. THE CLINICIAN DETERMINED THAT THE REACTION TO THE PATCHES REQUIRED MEDICAL INTERVENTION AND PRESCRIBED A CRèME INTENDED FOR BURNS WHICH IS NOT MEANT TO TREAT CONTACT DERMATITIS OR ALLERGIC REACTIONS. DESPITE THE CHOSEN CREAM, THE REDNESS AND TISSUE LOSS SHOWED IMPROVEMENT AND NO INDICATION OF ANY LASTING HARM. THE POTENTIAL ALLERGIC REACTION OR CONTACT DERMATITIS REACTION DESCRIBED IN THE COMPLAINT WAS NOT LIFE-THREATENING AND WOULD NOT HAVE CAUSED A PERMANENT IMPAIRMENT OR PERMANENT DAMAGE TO A BODY FUNCTION/STRUCTURE EVEN WITHOUT THE TOPICAL TREATMENT GIVEN. THUS THE REPORTABILITY CRITERIA HAVE NOT BEEN MET. THIS EVENT WAS NOT REPORTABLE. THIS EVENT WAS REVIEWED BY GE HEALTHCARE MEDICAL DIRECTOR. THE NOVII PATCHES DO NOT EMIT HEAT AND THERE WAS NO MALFUNCTION THUS A BURN REACTION IS NOT POSSIBLE. THE CLINICIAN DETERMINED THAT THE REACTION TO THE PATCHES REQUIRED MEDICAL INTERVENTION AND PRESCRIBED A CRèME INTENDED FOR BURNS WHICH IS NOT MEANT TO TREAT CONTACT DERMATITIS OR ALLERGIC REACTIONS. DESPITE THE CHOSEN CREAM, THE REDNESS AND TISSUE LOSS SHOWED IMPROVEMENT AND NO INDICATION OF ANY LASTING HARM. THE POTENTIAL ALLERGIC REACTION OR CONTACT DERMATITIS REACTION DESCRIBED IN THE COMPLAINT WAS NOT LIFE-THREATENING AND WOULD NOT HAVE CAUSED A PERMANENT IMPAIRMENT OR PERMANENT DAMAGE TO A BODY FUNCTION/STRUCTURE EVEN WITHOUT THE TOPICAL TREATMENT GIVEN. THUS THE REPORTABILITY CRITERIA HAVE NOT BEEN MET. THIS EVENT WAS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. UNIQUE IDENTIFIER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THERE WAS TISSUE LOSS AND SMALL SPOTS UNDER 3 OF THE 5 CIRCULAR GRAY PATCH LEADS WHERE GLUE IS ON THE PATCH AND REDNESS UNDER ALL 5 OF THE PATCHES OF APPROXIMATELY 5CM AREA. SILVADENE CREAM WAS ORDERED BY THE DOCTOR TO BE APPLIED TO THE AFFECTED AREAS. BEFORE DISCHARGE OF THE PATIENT, THE DOCTOR NOTED IMPROVEMENT WITH USE OF THE SILVADINE CREAM. ADEQUATE WOUND HEALING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105884 MONICA NOVII WIRELESS PATCH SYSTEM UTERINE ELECTROMYOGRAPHIC MONITOR OSP MONICA HEALTHCARE LTD 107-PT-001-1

    Patients

    Seq Age Sex Outcome Treatment
    1