BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19719175 · Received July 11, 2024

    Report

    Report Number
    1417592-2024-00725
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 11, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE REXALL ADVANCED ANTIBACTERIAL XL WATERPROOF BANDAGES, 10CT THAT HE PURCHASED JUST A FEW WEEKS AGO, CAUSED HIM AN ALLERGIC REACTION. HE SAID THAT HE HAD A WOUND ON HIS LEFT ARM, SO HE USED THE PRODUCT ON IT, THEN HE TOOK A SHOWER WITH THE PRODUCT STILL ON HIS SKIN, WHEN HE TOOK IT OFF, HIS WOUND BECAME EVEN MORE INFECTED. HE WENT TO HIS DOCTOR, AND HE WASN'T ABLE TO REALIZE THAT SKIN BECAME INFECTED DUE TO THE PRODUCT. HE SAID THAT HIS SKIN LOOKED LIKE IT HAS BLISTERS." 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, "THE REXALL ADVANCED ANTIBACTERIAL XL WATERPROOF BANDAGES, 10CT THAT HE PURCHASED JUST A FEW WEEKS AGO, CAUSED HIM AN ALLERGIC REACTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379630 RX ADV AB W/P XL H/DUTY 10CT FRO MEDLINE INDUSTRIES LP 230503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other