BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KROGER HEAVY FABRIC STRONG STRIPS ANTIBACTERIAL 1"

    MDR report key: 4948756 · Received July 27, 2015

    Report

    Report Number
    1038758-2015-00050
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 23, 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

    THE PRINTED BOX LABELING INDICATES THAT THE PRODUCT HAS A SUPER STRENGTH ADHESIVE AND IS NOT INTENDED FOR USE ON DELICATE OR SENSITIVE SKIN. CUSTOMER DID NOT SEE THE DISCLAIMER.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE END USER REPORTED THAT THE ADHESIVE ON THE DEVICE PULLED TWO LAYERS OF SKIN OFF HER ARM. THE SPOT WAS BLEEDING AND SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485673 KROGER HEAVY FABRIC STRONG STRIPS ANTIBACTERIAL 1" HEAVY FABRIC STRONG STRIPS ANTIBAC KGX ASO LLC UPC: 4126034178 27455

    Patients

    Seq Age Sex Outcome Treatment
    1