BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGET

    MDR report key: 3001471 · Received March 7, 2013

    Report

    Report Number
    1038758-2013-00012
    Event Type
    Other
    Date Received
    March 7, 2013
    Date of Event
    June 7, 2012
    Report Date
    March 6, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED RESULTING FROM AN FDA INSPECTION AT THE MFR ON (B)(4) 2012 WHERE THE MFR WAS CITED FOR FAILURE TO MAKE MULTIPLE ATTEMPTS TO OBTAIN INFO FOR MDR DECISIONS.

    Description of Event or Problem · 1

    THE CONSUMER COMPLAINED THAT THE BANDAGE CAUSED SWELLING, BUMPS AND BAD ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98050 TARGET ADHESIVE BANDAGES KGX ASO LLC 017276225198 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other