BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NF SILICONE FOLEY CATHETER

    MDR report key: 1604082 · Received February 8, 2010

    Report

    Report Number
    MW5014747
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 8, 2010
    Report Date
    February 8, 2010
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSERTED 16 GA FOLEY WITH NO IMMEDIATE URINE RETURNS. CONFIRMED PLACEMENT, STILL NO URINE OUTPUT AFTER TWO LITERS OF FLUIDS. UNABLE TO IRRIGATE CATHETER, BEDSIDE SONOGRAM COMPLETED, NO KINKS NOTED. BALLOON DEFLATED AND CATHETER READVANCED WITHOUT DIFFICULTY; NO URINE OUTPUT. ATTEMPTED REIRRIGATION UNSUCCESSFUL. FOLEY CATHETER DISCONTINUED. ON INSPECTION OF CATHETER, FOUND THE TIP HAD NO DRAINAGE HOLES. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: LEFT RENAL CALCULUS, DIFFICULTY VOIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NF SILICONE FOLEY CATHETER FOLEY CATHETER KOD ROCHESTER MEDICAL CORP. 53311213

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR