BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMSOFT

    MDR report key: 2309996 · Received October 20, 2011

    Report

    Report Number
    2130787-2011-00002
    Event Type
    Other
    Date Received
    October 20, 2011
    Date of Event
    March 27, 2008
    Report Date
    October 14, 2011
    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 PATIENT RECEIVED SOME FEMSOFT URETHRAL INSERTS SAMPLES TO TRY FROM HER CLINICIAN. THE CLINICIAN INSERTED A SAMPLE. THE PATIENT LEFT THE CLINICIAN'S OFFICE AND LATER REPORTED A SLIGHT SENSATION SHE COULD NOT DESCRIBE. THE PATIENT VISITED AN EMERGENCY ROOM THINKING THE FEMSOFT DEVICE HAD MIGRATED. AN X-RAY WAS TAKEN IN THE EMERGENCY ROOM, BUT THE DEVICE COULD NOT BE SEEN IN THE X-RAY. THE PATIENT THEN CONTACTED CUSTOMER SERVICE AND THE PATIENT WAS PROVIDED A LIST OF REGISTERED FEMSOFT CLINICIANS FOR HER AREA. THE PATIENT VISITED ONE OF THE REGISTERED CLINICIANS AND THE DEVICE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMSOFT URETHRAL INSERT OCK ROCHESTER MEDICAL CORP. 71201 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other