BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLEY CATH SIL-ELASTOMER 30FR

    MDR report key: 2083093 · Received April 28, 2011

    Report

    Report Number
    1417592-2011-00022
    Event Type
    Other
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 25, 2011
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD A SCHEDULED SUPRAPUBIC CATHETER CHANGE ON (B)(6) 2011. (B)(6) DAYS LATER, IT WAS REPORTED THAT THE CATHETER HAD FLATTENED AND WAS NOT DRAINING PROPERLY. A NEW CATHETER WAS PLACED UNDER GENERAL ANESTHESIA. THE PATIENT WAS REPORTED TO BE DOING WELL AND THE REPLACEMENT CATHETER HAS BEEN FUNCTIONING WELL. THE ROUTINE CATHETER CHANGES FOR THIS PATIENT ARE DONE IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA. INFORMATION WAS NOT PROVIDED AS TO WHY THIS IS NECESSARY. IT IS NOT KNOWN IF ATTEMPTS WERE MADE TO IRRIGATE THE CATHETER. THE CONDITION OF THE URINE OR PRESENCE OF SEDIMENT IS ALSO NOT KNOWN. THE SAMPLE WAS NOT RETAINED FOR EVALUATION. NO DESCRIPTION OF THE CATHETER WAS PROVIDED. THE ACCOUNT HAS NOT HAD ANY OTHER SIMILAR INCIDENTS AND THE PATIENT HAS BEEN USING THIS PARTICULAR CATHETER WITHOUT PREVIOUS ISSUE. A ROOT CAUSE HAS NOT BEEN DETERMINED. DURING THE LAST YEAR, WE HAVE HAD NO OTHER SIMILAR COMPLAINTS. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME. DUE THE REPORTED NEED FOR SURGICAL REPLACEMENT OF THE CATHETER, A MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    REPORT THAT CATHETER FLATTENED, REQUIRED SURGICAL REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATH SIL-ELASTOMER 30FR NONE KOD DYND11770 494054R001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention