BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURECARE PROTECTIVE UNDRWR LGE

    MDR report key: 2831321 · Received November 2, 2012

    Report

    Report Number
    1033903-2012-00001
    Event Type
    Other
    Date Received
    November 2, 2012
    Report Date
    October 11, 2012
    Manufacturer
    COVIDIEN
    Product Code
    EYQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN ADULT BRIEF. THE CUSTOMER REPORTS THAT SHE USED THE SURECARE PROTECTIVE UNDERWEAR WHILE AS AN INPATIENT AT A MEDICAL FACILITY AND SHE DEVELOPED A RASH. THE DOCTOR PRESCRIBED TRIAMCINOLONE .5% TOPICAL CREAM. THE PT HAS SINCE BEEN RELEASED AND HER CONDITION HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURECARE PROTECTIVE UNDRWR LGE ADULT BRIEF EYQ COVIDIEN 1603 12124G070617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other