BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM SOFT

    MDR report key: 2359817 · Received November 30, 2011

    Report

    Report Number
    2130787-2011-00004
    Event Type
    Injury
    Date Received
    November 30, 2011
    Report Date
    November 30, 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

    A REPORT WAS RECEIVED FROM A DISTRIBUTOR. THE REPORT STATES THAT THE PT'S HUSBAND HAD CALLED THE DISTRIBUTOR CONCERNING A REFUND FOR SOME FEMSOFT PRODUCT THAT HAD BEEN RETURNED TO THE DISTRIBUTOR MONTHS AGO. THE PT'S HUSBAND STATED THAT THE PT HAD INTERNAL BLEEDING FROM USING A FEMSOFT DEVICE. THE PT'S HUSBAND STATED THAT THE PT'S PHYSICIAN TOLD HER TO STOP USING THE PRODUCT. THE PT'S HUSBAND STATED THAT THE PT HAD A CUT AT THE BASE OF THE PT'S BLADDER AND LARGE BLOOD CLOTS WERE OBSERVED. THE PT'S HUSBAND STATED THE PT COLLAPSED AT A DOCTOR'S OFFICE AND HAD LOST 2 LITERS OF BLOOD CAUSING HER TO BE RUSHED TO THE EMERGENCY ROOM. THE PT'S HUSBAND STATED HIS WIFE WAS IN AN INTENSIVE CARE UNIT FOR 3 DAYS. NO SAMPLES OR PRODUCT INFO WAS AVAILABLE DUE TO THE RETURN OF THE UNUSED PRODUCT TO THE DISTRIBUTOR AND THE DISCARDING THE USED FEMSOFT DEVICE. NO PHYSICIAN OR HOSPITAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEM SOFT URETHRAL INSERT OCK ROCHESTER MEDICAL CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization