BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M CAVILON ADVANCED SKIN PROTECTANT

    MDR report key: 6133558 · Received November 29, 2016

    Report

    Report Number
    2110898-2016-00106
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 9, 2016
    Manufacturer
    3M HEALTH CARE
    Product Code
    KMF
    PMA / PMN Number
    K153571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE REPORTED SHE APPLIED 5050 CAVILON ADVANCED SKIN PROTECTANT TO HER INNER ARM AND THIGH AS A TRIAL. SHE REPORTEDLY EXPERIENCED ITCHING AND INITIALLY AND USED OTC ORAL BENADRYL AND TOPICAL HYDROCORTISONE FOR TREATMENT. THREE DAYS AFTER APPLICATION TO HER INNER ARM SHE REPORTEDLY EXPERIENCED CONTACT DERMATITIS (ITCHING AND HIVES) AND SELF TREATED WITH A MEDROL DOSEPACK AND OTC HYDROCORTISONE CREAM. THE FOLLOWING DAY THE REACTION FELT BETTER BUT REPORTEDLY RETURNED NINE DAYS LATER. SHE ALSO REPORTEDLY EXPERIENCED A CONTACT DERMATITIS (ITCHING AND HIVES) THREE DAYS AFTER APPLICATION TO HER THIGH. SHE SAW A DERMATOLOGIST WHO REPORTEDLY DIAGNOSED THIS AS A REACTION TO 5050 CAVILON ADVANCED SKIN PROTECTANT. THE DERMATOLOGIST RECOMMENDED BENADRYL (ORAL) 50 MG AT NIGHT, ALLEGRA 180 MG EVERY DAY X 2 WEEKS, AND TOPICAL RX FLUOCINONIDE 0.05% CREAM FOR TREATMENT. THE RASH WAS REPORTEDLY IMPROVING. SHE REPORTEDLY HAS SENSITIVE SKIN, SENSITIVITY TO ADHESIVES, A HISTORY OF MANY ALLERGIES AND HAS EXPERIENCED HIVES TO BOTH PCN AND LATEX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781830 3M CAVILON ADVANCED SKIN PROTECTANT CAVILON ADVANCED SKIN PROTECTANT KMF 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other