BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREENS

    MDR report key: 2915198 · Received January 10, 2013

    Report

    Report Number
    1038758-2013-00002
    Event Type
    Other
    Date Received
    January 10, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ASO LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, THE END-USER REPORTED THAT HE STILL HAS SOME OF THE PRODUCT AND CAN RETURN IT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED THAT THE END-USER CLAIMS THE DEVICE IRRITATED HIS NOSE MAKING IT DRY AND SCALY. ON (B)(6) 2012, THE END-USER REPORTED THAT THE DEVICE BURNED AND TOOK OFF SKIN FROM HIS NOSE. CLAIMS THE MARK STILL SHOWS AFTER 3 WEEKS, BUT HAS NOT SOUGHT MEDICAL TREATMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15781 WALGREENS NASAL STRIPS LWF ASO LLC 31191710786 A141952

    Patients

    Seq Age Sex Outcome Treatment
    1