BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMSOFT INSERT

    MDR report key: 1692197 · Received May 13, 2010

    Report

    Report Number
    2130787-2010-00002
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    May 5, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT CONTACTED HER FEMSOFT INSERT DISTRIBUTOR AND TOLD THEM SHE HAD A BURNING SENSATION FOR THREE WEEKS. THE DISTRIBUTOR CUSTOMER SERVICE REP ENCOURAGED THE PT TO CONTACT HER PHYSICIAN AND TO DISCONTINUE USING THE FEMSOFT INSERTS. THE PT STATED SHE STARTED USING THE FEMSOFT INSERTS (B)(6) 2010 AND DISCONTINUED USAGE OF THE INSERTS (B)(6) 2010. THE PT CONTACTED A ROCHESTER MEDICAL CUSTOMER SERVICE REP ON (B)(6) 2010 AND STATED HAD A KIDNEY INFECTION. THE PT REPORTED SHE VISITED A PHYSICIAN AND WAS PRESCRIBED CEPHLAX AND BACTRIM. THE PT STATED THAT SHE HAS NO CONTROL OVER HER BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMSOFT INSERT URETHRAL INSERT OCK ROCHESTER MEDICAL CORP. 53500598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other