BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELVAREX CCL 2, KNEE HIGH, OPEN TOE, COLOR BLUE

    MDR report key: 2655585 · Received June 29, 2012

    Report

    Report Number
    8043565-2012-00001
    Event Type
    Other
    Date Received
    June 29, 2012
    Date of Event
    May 30, 2012
    Report Date
    June 28, 2012
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS RETURNED TO MANUFACTURER AND WILL BE SENT TO LABORATORY TO UNDERGO EPICUTAN TEST FOLLOWING DIN EN ISO 10993-10:2010-12.

    Description of Event or Problem · 1

    PATIENT REPORTS ADVERSE REACTION LIKE BLISTERS AND RASHES AT BOTH LEGS ("ALLERGY") AFTER HE STARTED TO WEAR MEDICAL COMPRESSION STOCKINGS FOR > 3 HOURS (REPORTED IN A LETTER TO BSN - (B)(4) RECEIVED 06/19/2012). THERAPY DATE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELVAREX CCL 2, KNEE HIGH, OPEN TOE, COLOR BLUE MEDICAL COMPRESSION STOCKINGS DWL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other VITAMIN-K-ANTAGONIST