BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION PRM 16FR CATH SECURE

    MDR report key: 2848710 · Received October 25, 2012

    Report

    Report Number
    9612030-2012-00052
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. MAUDE EVENT REPORT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A FOLEY CATHETER. THE CUSTOMER REPORTS THE FOLEY CATHETER WAS FOUND IN THE PT¿S BED WITH DEFLATED BALLOON. PT WAS POSTOPERATIVE DAY NUMBER 3 FROM ROBOTIC CYSTOPROSTECTOMY WITH PELVIC NODE BIOPSY AND NEOBLADDER. FAILURE OF FOLEY CATHETER REQUIRED BEDSIDE CYSTOSCOPY WITH REINSERTION OF NEW CATHETER. THE CUSTOMER STATED THAT THERE WAS NO CONSEQUENCE TO THE PT. THE PT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION PRM 16FR CATH SECURE FOLEY CATHETER EZL COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX PP16XSD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other