BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HYDROCOLLOID 2.3" X 3" - 4CT

    MDR report key: 4894178 · Received July 1, 2015

    Report

    Report Number
    1038758-2015-00042
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    EUROMED INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER SIMILAR COMPLAINTS RECEIVED. PENDING RESPONSE FROM CONSUMER.

    Description of Event or Problem · 1

    ON (B)(6) 2015 - THE END USER REPORTED THAT SHE HAS BEEN USING THE DEVICE FOR BED SORES; HER SKIN IS TURNING DARK PURPLE AROUND THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426470 CVS HYDROCOLLOID 2.3" X 3" - 4CT HYDROCOLLOID BANDAGES KGX EUROMED INC UPC 5042839793

    Patients

    Seq Age Sex Outcome Treatment
    1