BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NF SILICONE FOLEY CATHETER

    MDR report key: 1604086 · Received February 8, 2010

    Report

    Report Number
    MW5014748
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    October 30, 2009
    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

    TRIED TO REMOVE FOLEY CATHETER FROM PT, BUT FELT RESISTANCE AND PT FELT PAIN. ASKED ANOTHER STAFF MEMBER TO ASSIST IN REMOVAL OF CATHETER, HE ALSO COULD NOT REMOVE CATHETER WITHOUT CAUSING PT PAIN. ASKED FOR ASSISTANCE FROM THE UROLOGY UNIT. TWO NURSES ATTEMPTED TO REMOVE FOLEY, THEY ALSO MET RESISTANCE, BUT WERE ABLE TO REMOVE THE CATHETER INTACT. DATES OF USE: (B) (6) 2009 - (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: TO COLLECT 24-HOUR URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NF SILICONE FOLEY CATHETER FOLEY CATHETER KOD ROCHESTER MEDICAL CORP. 53310885

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR