BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER SHEER ANTIBACTERIAL 3" X 4" 10CT.

    MDR report key: 4948751 · Received July 27, 2015

    Report

    Report Number
    1038758-2015-00053
    Event Type
    Injury
    Date Received
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING INDICATES THAT THE BANDAGES HAVE A PAD WITH AN ACTIVE INGREDIENT BENZALKONIUM CHLORIDE 0.1%.

    Description of Event or Problem · 1

    ON 06/25/15, THE END USER REPORTED THAT SHE HURT HERSELF WHEN USING THE DEVICE. ON (B)(6) 2015, THE END USER CLARIFIED THE STATEMENT. SHE USED THE DEVICE TO COVER AN INCISION ON HER BACK 2 DAYS AFTER THE PROCEDURE. SHE EXPERIENCED SOME DISCOMFORT AND ITCHING, BY THE SECOND DAY THE PAIN AND ITCHING WERE UNBEARABLE, REMOVED THE DEVICE, THE SKIN WAS BRIGHT RED, INFLAMED SQUARE OF SKIN IN THE SAME SIZE AND SHAPE OF THE PAD PORTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485570 KROGER SHEER ANTIBACTERIAL 3" X 4" 10CT. ADHESIVE BANDAGES KGX ASO LLC UPC 4126034179 24415

    Patients

    Seq Age Sex Outcome Treatment
    1