BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMSOFT INSERT

    MDR report key: 280335 · Received May 31, 2000

    Report

    Report Number
    2130787-2000-00007
    Event Type
    Injury
    Date Received
    May 31, 2000
    Date of Event
    May 9, 2000
    Report Date
    May 16, 2000
    Manufacturer
    ROCHESTER MEDICAL CORPORATION
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADULT PT REPORTED TO CLINICAL INVESTIGATOR FOR STUDY F/U APPT. ROUTINE URINE CULTURE = KLEBSIELLA > 100,000. MD ELECTED TO TREAT - ASYMPTOMATIC URINARY TRACT INFECTION WITH LEVAQUIN 500 MG X 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMSOFT INSERT FEMALE TRANSURETHRAL OCCLUSION DEVICE MNG ROCHESTER MEDICAL CORPORATION * 3M0130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention