BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NR 18 NOAH

    MDR report key: 317401 · Received February 21, 2001

    Report

    Report Number
    1219103-2001-00001
    Event Type
    Injury
    Date Received
    February 21, 2001
    Date of Event
    January 1, 2001
    Report Date
    February 20, 2001
    Manufacturer
    KENDALL-LTP / A BUSINESS UNIT OF THE LUDLOW COMPANY LP
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS BORN PREMATURE AT 23 WEEKS OF GESTATION. THE PT WAS KNOWN TO HAVE A GLOBAL, FUNGAL SKIN INFECTION. THE NR 18 NOAH ECG ELECTRODE WAS USED ON PATIENT. THE ELECTRODE WAS NOTED TO HAVE LEFT A REDDENED, IRRITATED MARK ON ARM. NO MEDICAL TREATMENT WAS SPECIFICALLY GIVEN AND THERE WERE NO DERMATOLOGY CONSULTS. THE PT DID HAVE SKIN LOTION APPLIED TO ALL AREAS OF BODY PER STANDARD TREATMENT OF CARE. AT THIS TIME, THE PT IS ALIVE AND WELL. THE PT'S PARENT INDICATED TO THE REPORTER INDICATED THAT THE MARK ON ARM MAY NEED SKIN GRAFTING. IT IS UNKNOWN BY MANUFACTURER IF SKIN GRAFT IS NECESSARY, AND IF SO, WHETHER IT IS FOR COSMETIC OR THERAPEUTIC REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6787 NR 18 NOAH ECG ELECTRODE DRX KENDALL-LTP / A BUSINESS UNIT OF THE LUDLOW COMPANY LP EP30089 517093

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DAY Disability