BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17390146 · Received July 25, 2023

    Report

    Report Number
    1417592-2023-00313
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 2, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THE USER EXPERIENCED A REACTION FROM THE BANDAGE THAT WAS DESCRIBED AS SWELLING AND REDNESS TO THEIR ARM. PER THE CUSTOMER THEY DID NOT USE OINTMENTS, LOTIONS PRIOR TO USING THE BANDAGE. PER THE CUSTOMER THE REACTION OCCURRED WITHIN A FEW HOURS AFTER THE BANDAGE WAS APPLIED TO "CLEAN SKIN". PER THE CUSTOMER THE USER WAS PRESCRIBED MUPIROCIN 2% THREE TIMES A DAY. PER THE CUSTOMER THE USERS SKIN IS STILL RAW AND BEING TREATED. SAMPLE REQUESTED TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, 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 ON (B)(6) 2023, THE USER EXPERIENCED A REACTION FROM THE BANDAGE THAT WAS DESCRIBED AS SWELLING AND REDNESS TO THEIR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809693 RX ADV AB W/P XL H/DUTY 10CT KGX MEDLINE INDUSTRIES, LP 220701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other