BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL MEDIUM ADULT BRIEF

    MDR report key: 1714440 · Received June 2, 2010

    Report

    Report Number
    1033903-2010-00002
    Event Type
    Other
    Date Received
    June 2, 2010
    Report Date
    May 24, 2010
    Manufacturer
    COVIDIEN
    Product Code
    EYQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH AN ADULT BRIEF. THE CUSTOMER STATES THAT THE PT HAD A SEVERE REACTION TO THE INNER BLUE ABSORBENT AREA OF THE BRIEF. THE DR PRESCRIBED TRIAMCINOLONE .5% TOPICAL CREAM FOR TREATMENT OF THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL MEDIUM ADULT BRIEF ADULT BRIEF EYQ COVIDIEN 60033 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR