BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NF SILICONE FOLEY CATHETER

    MDR report key: 1604078 · Received February 8, 2010

    Report

    Report Number
    MW5014746
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    February 2, 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

    FOLEY CATHETER BEING DISCONTINUED, BUT MULTIPLE STAFF UNABLE TO COMPLETELY DEFLATE BULB OF CATHETER. BULB WAS REINFLATED, THEN DEFLATED; CATHETER WAS EVENTUALLY REMOVED WITHOUT DIFFICULTY. PT WAS READMITTED TO THE HOSPITAL ON (B) (6) 2010, DUE TO INABILITY TO URINATE. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NF SILICONE FOLEY CATHETER FOLEY CATHETER KOD ROCHESTER MEDICAL CORP. 53310769

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR