BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBD-RX ADV AB W/P H/DUTY STRP 20CT

    MDR report key: 10906347 · Received November 25, 2020

    Report

    Report Number
    1417592-2020-00138
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER INDICATED THAT THE BANDAGE WAS APPLIED TO HER UMBILICUS AFTER REMOVING AN UMBILICAL PIERCING THAT REPORTEDLY BECAME INFECTED. WHILE THE BANDAGE WAS ON, THE END-USER EXPERIENCED ITCHING TO THE APPLICATION SITE. REPORTEDLY, THE BANDAGE WAS ON FOR LESS THAN TWENTY-FOUR (24) HOURS AND WHEN IT WAS REMOVED THE END-USER NOTED SHE HAD EXPERIENCED A RASH TO THE SKIN IN CONTACT WITH THE BANDAGE ADHESIVE. THE END-USER REPORTEDLY APPLIED HYDROCORTISONE CREAM TO THE SITE AND LATER WENT TO AN URGENT CARE CENTER WHERE SHE WAS EVALUATED AND DISCHARGED HOME WITH A PRESCRIPTION FOR AN UNSPECIFIED STEROID CREAM. ACCORDING TO THE END-USER THE STEROID CREAM MADE HER RASH WORSE AND SHE WAS PRESCRIBED A TRIAMCINOLONE CREAM INSTEAD. THE TRIAMCINOLONE CREAM HAS REPORTEDLY BEEN EFFECTIVE IN TREATING THE RASH. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE WAS FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED NEED FOR PRESCRIBED MEDICAL TREATMENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END-USER EXPERIENCED A RASH AND REQUIRED PRESCRIBED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364325 DBD-RX ADV AB W/P H/DUTY STRP 20CT KGX MEDLINE INDUSTRIES INC. 19071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention