BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMSOFT INSERT

    MDR report key: 1748844 · Received June 29, 2010

    Report

    Report Number
    2130787-2010-00001
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 27, 2010
    Manufacturer
    ROCHESTER MEDICAL CORP
    Product Code
    OCK
    PMA / PMN Number
    P990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS USING FEMSOFT URETHRAL INSERT SAMPLES PROVIDED TO HER BY HER PHYSICIAN. THE CUSTOMER REPORTED THAT SHE EXPERIENCED IRRITATION THE FIRST TIME SHE USED TO FEMSOFT INSERTS. THE CUSTOMER REPORTED THAT SHE QUIT USING THE FEMSOFT INSERTS ON (B)(6) 2010 DUE TO THE CUSTOMER FEELING LIKE SHE HAD AN INFECTION. THE CUSTOMER REPORTED THAT SHE WENT TO A LOCAL CLINIC AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION. THE CUSTOMER REPORTED THE PHYSICIAN PRESCRIBED AN ANTIBIOTIC FOR THE CUSTOMER TO TREAT THE UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMSOFT INSERT URETHRAL INSERT OCK ROCHESTER MEDICAL CORP 53500458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other