BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBER'S MARK

    MDR report key: 7076102 · Received December 1, 2017

    Report

    Report Number
    1038758-2017-00046
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 6, 2017
    Manufacturer
    ASO LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 12/01/2017 CONSUMER DID NOT RETURN UNUSED SAMPLES FOR FURTHER INVESTIGATION. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS, LATEX SCREENING ON ADHESIVE AND ADHESION PROPERTIES ON SAMPLES ASSOCIATED WITH THE PRODUCT. REFER TO SECTION FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT PRODUCT CAUSED HIM SERIOUS UNDER EYE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854295 MEMBER'S MARK EXTRA STRENGTH NASAL STRIPS LWF ASO LLC UPC#078742094656

    Patients

    Seq Age Sex Outcome Treatment
    1