BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDIUM SLIP ON BRIEF

    MDR report key: 3463490 · Received November 5, 2013

    Report

    Report Number
    1033903-2013-00001
    Event Type
    Other
    Date Received
    November 5, 2013
    Report Date
    October 15, 2013
    Manufacturer
    COVIDIEN
    Product Code
    EYQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A BRIEF. THE CUSTOMER STATES THAT SHE RECEIVED A RASH FROM THE USE OF THE PRODUCT AND IT CAUSED HER TO HAVE A BLADDER INFECTION. THE CUSTOMER FURTHER REPORTS THAT SHE WENT TO HER DOCTOR WHO PRESCRIBED HER CIPROFLOXACIN ORALLY 50 MG AND NYSTATIN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569485 MEDIUM SLIP ON BRIEF BRIEF EYQ COVIDIEN 1605 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other