BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE FABRIC ANTIBACTERIAL XL 10CT. BANDAGES

    MDR report key: 5048634 · Received August 31, 2015

    Report

    Report Number
    1038758-2015-00068
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DATA: PER DEVICE EVALUATED BY MANUFACTURER - EVALUATION OF A REPRESENTATIVE SAMPLE OF THE RELATED MEDIAL DEVICE IS SUMMARIZED. ADDITIONAL NARRATIVE: CONSUMER / END USER PLANNED TO SEEK MEDICAL ATTENTION FOR THIS EVENT. ASO / MANUFACTURER REACHED OUT TO CONSUMER / END USER ON 2 OCCASIONS TO REQUEST THE RETURN OF REMAINING DEVICE PRODUCT FOR INVESTIGATION AND TESTING; TO DATE THERE HAS BEEN NO RESPONSE.

    Description of Event or Problem · 1

    THE CONSUMER/END USER REPORTED THAT THE DEVICE TORE A CUT IN HER SKIN AND NOW SHE HAS A BIG HOLE IN HER SKIN THAT TOOK OFF ABOUT TEN LAYERS OF SKIN. THE END USER REPORTED THAT SHE GENTLY PULLED THE DEVICE PRODUCT OFF AND IT IS BURNING. NEOSPORIN WAS USED BY THE END USER TO TREAT THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575951 EQUATE FABRIC ANTIBACTERIAL XL 10CT. BANDAGES ADHESIVE BANDAGES KGX ASO LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR