BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ADV AB W/P XL H/DUTY 10CT

    MDR report key: 19732193 · Received July 12, 2024

    Report

    Report Number
    1417592-2024-00735
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "IT WAS PLACED UNDER MY 6 YEAR OLD GRANDDAUGHTER'S ARM AND SOON AFTER THERE WAS A RED OUTLINE AROUND THE BANDAGE. ONCE WE TOOK IT OUT, WE NOTICED REDNESS AND WHITE BLISTERS. WE WENT TO THE DERMATOLOGIST AND HE GAVE US A PRESCRIPTION CREAM, IT WAS NOT OVER THE COUNTER. IT IS STILL RED BUT BETTER NOW". A SAMPLE IS NOT AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "IT WAS PLACED UNDER MY 6 YEAR OLD GRANDDAUGHTER'S ARM AND SOON AFTER THERE WAS A RED OUTLINE AROUND THE BANDAGE. ONCE WE TOOK IT OUT, WE NOTICED REDNESS AND WHITE BLISTERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911537 RX ADV AB W/P XL H/DUTY 10CT FRO MEDLINE INDUSTRIES LP 230801

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Other