BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7911275 · Received September 26, 2018

    Report

    Report Number
    1820334-2018-02786
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Date of Event
    August 9, 2018
    Report Date
    October 24, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AGE OR DATE OF BIRTH, SEX, WEIGHT. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION THE DEVICE WAS NOT RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. NO LOT NUMBER WAS PROVIDED; THEREFORE, A REVIEW OF NON-CONFORMANCES CANNOT BE COMPLETED AT THIS TIME. NO LOT NUMBER WAS PROVIDED THEREFORE NO ADDITIONAL COMPLAINTS CAN BE REVIEWED AT THIS TIME. A REVIEW OF INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA WAS CONDUCTED. NO COMPLAINT PRODUCT AND PHOTO HAVE BEEN RETURNED FOR ASSESSMENT AND PHYSICAL EVALUATION. THE INSTRUCTIONS FOR USE (IFU) INCLUDES THE FOLLOWING INFORMATION: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. THIS PRODUCT COMES TO COOK INC. FROM A SUPPLIER AND CURRENT CONTROLS FOR THE QUALITY CONTROL ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. BASED ON THE PROVIDED INFORMATION INVESTIGATION CONCLUSION CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATED PERSONNEL OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    FURTHER EVENT DETAILS WERE OBTAINED (B)(6) 2018: THE CUSTOMER WAS UNABLE TO PROVIDE THE DATE THE DEVICE WAS INDWELT. THE CUSTOMER ADVISED, THEY DID NOT KNOW WHAT CAUSED THE SEVERING.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K091767. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE UNIVERSA SILICONE FOLEY CATHETER WAS FOUND IN THE PATIENT'S BED. THE BALLOON WAS INTACT, THE CATHETER SEVERED CLEAN JUST BELOW THE CONNECTIONS. A NEW CATHETER WAS SET UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750241 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR