BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUSH URETERAL ILLUMINATING CATHETER SET

    MDR report key: 3124043 · Received May 17, 2013

    Report

    Report Number
    1820334-2013-00194
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    FCS
    PMA / PMN Number
    K923436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN AS LOT IS UNKNOWN. BURNING AND BLISTERING FROM HEAT ARE NOT LABELED IN THE IFU. THE COMPLAINT DEVICE WAS NOT RETURNED, SO NO PHYSICAL EVALUATION COULD BE PERFORMED. ALSO, THE CUSTOMER WAS UNRESPONSIVE TO REPEATED ATTEMPTS TO GET ANSWERS TO QUESTIONS THAT WOULD AID IN THE INVESTIGATION. BASED PURELY ON THE DESCRIPTION OF THE EVENT, IT IS MOST LIKELY THAT THE CUSTOMER WAS USING A HIGH-ENERGY LIGHT SOURCE THAT CAUSED THE FITTING OF THE CATHETER TO BECOME HOT AND RESULTED IN THE BURN. THE INSTRUCTIONS FOR USE FOR THE DEVICE STATES: HIGH ENERGY LIGHT SOURCE SUCH AS XENON MAY CAUSE OVERHEATING OF THE ANODIZED ALUMINUM PLUG. AN APPROPRIATE ADAPTER WILL ENSURE PRODUCT SAFETY AND FUNCTIONALITY. ALTHOUGH THE DEVICES ARE 100% INSPECTED, COOK CANNOT CONTROL LIGHT SOURCE/SETTINGS UTILIZED BY THE CUSTOMER. THE CAUSE OF THIS EVENT WAS MOST LIKELY THE CUSTOMER'S USE OF A HIGH-ENERGY LIGHT SOURCE, WHICH CAUSED THE FITTING TO BECOME HOT AND RESULTED IN A BURN TO THE PATIENT. WE CONTINUE TO MONITOR FOR SIMILAR EVENTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. DUE TO THE PRODUCT NOT BEING RETURNED AND LOW OVERALL RISK TO PATIENT, NO CORRECTIVE ACTION WAS INITIATED.

    Description of Event or Problem · 1

    A DIME SIZE AREA OF REDNESS WAS NOTED ON THE PATIENT'S THIGH WHEN TRANSFERRING PATIENT TO BED AT 1440. AT 1630 PATIENT COMPLAINT OF SEVERE PAIN. THE AREA HAD INCREASED IN SIZE AND WAS BLISTERED. AREA WAS TREATED IN HOSPITAL WITH TOPICAL ANTIBIOTIC. PATIENT IS NOW BEING FOLLOWED UP ON BY PLASTIC SURGEON. NO ADDITIONAL PATIENT OUTCOME WAS PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218855 BUSH URETERAL ILLUMINATING CATHETER SET FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL FCS COOK UROLOGICAL INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR