BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOPCO

    MDR report key: 2915196 · Received January 10, 2013

    Report

    Report Number
    1038758-2013-00001
    Event Type
    Other
    Date Received
    January 10, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED ON (B)(4) 2012; HOWEVER, IT WAS NOT UNTIL (B)(4) 2012 THAT THE MFR WAS INFORMED OF ANY POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER REPORTED THAT THE END-USER CLAIMS THE DEVICE CONTAINS LATEX. ON (B)(6) 2012, THE END-USER REPORTED THAT THE DEVICE CAUSED PAIN, BURNS AND SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14985 TOPCO ADHESIVE BANDAGES KGX ASO LLC 10036800106823 547960

    Patients

    Seq Age Sex Outcome Treatment
    1 Other