BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 8401643 · Received March 7, 2019

    Report

    Report Number
    1038758-2019-00005
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 5, 2019
    Manufacturer
    JIANGSU NANFANG MEDICAL CO. LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 03/04/2019 UNUSED SAMPLES OR LOT NUMBER WERE NOT PROVIDED. ASO HAS REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND NOTIFIED THE MANUFACTURER ABOUT THE EVENT.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON 02/05/2019 CONSUMER STATED THAT PRODUCT CAUSED A RASH. CONSUMER USED THE ADHESIVE TAPE TO HOLD GAUZE PADS AND NOTICED A RED RASH SURROUNDING THE INCISION AREA WHENEVER HE CHANGED THE GAUZE WHERE THE TAPE CAME IN CONTACT WITH HIS SKIN. CONSUMER STATED THAT HE REQUIRED MEDICAL TREATMENT. HIS DERMATOLOGIST INFORMED THAT THE RASH WAS CAUSED BY THE CONTACT WITH THE TAPE CAUSING A RASH DERMATITIS. A PRESCRIPTION WAS GIVEN TO THE CONSUMER TO CLEAR THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191342 CVS HEALTH WATERPROOF ADHESIVE TAPE KGX JIANGSU NANFANG MEDICAL CO. LTD. UPC#050428269084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other