BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS

    MDR report key: 4170512 · Received October 9, 2014

    Report

    Report Number
    1038758-2014-00031
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET SURVEILLANCE OF COMPLAINTS FOR SIMILAR REPORT FOR 2014 TO DATE REVEALED (B)(4).

    Description of Event or Problem · 1

    (B)(4), 2014 - THE CONSUMER USED THE PRODUCT TO COVER THE WOUND AFTER SURGICAL PROCEDURE (NAIL REMOVAL). THE CONSUMER REPORTED THAT THE PAD ADHERED TO THE WOUND RESULTING IN PAIN AND BLEEDING WHEN THE CONSUMER REMOVED THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636880 CVS NON-STICK PAD KGX ASO LLC 050428452813 2384-20140130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other