BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMSOFT INSERT

    MDR report key: 1692195 · Received May 13, 2010

    Report

    Report Number
    2130787-2010-00003
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 6, 2010
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    OCK
    PMA / PMN Number
    P990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT STATED SHE HAD EXPERIENCED TWO URINARY TRACT INFECTIONS. THE PT ESTIMATED THE FIRST UTI OCCURRED IN (B)(6) 2010, AND THE SECOND UTI WAS ESTIMATED TO HAVE OCCURRED IN (B)(6) 2010. THE PT STATED IN BOTH INSTANCES, SHE CONTACTED HER HOSPITAL'S TRIAGE NURSE AND RECEIVED A PRESCRIPTION FOR THE UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMSOFT INSERT URETHRAL INSERT OCK ROCHESTER MEDICAL CORP. 53500520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other