BEUDAMED
    FDA Adverse Event Death Summary report: N

    FOLEY CATHETER

    MDR report key: 5361083 · Received January 8, 2016

    Report

    Report Number
    MW5059257
    Event Type
    Death
    Date Received
    January 8, 2016
    Date of Event
    April 6, 2013
    Report Date
    November 6, 2013
    Manufacturer
    UNK
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY FATHER WAS PRESCRIBED TRAMADOL FOR EPIDIDYMITIS ORCHITIS. HE WAS HAVING EPISODES OF CONFUSION AND PROGRESSIVELY BECAME WORSE AFTER BEING IN A SKILLED NURSING FACILITY FOR 3 WEEKS. DURING MY FATHER'S 3 WEEKS AT A SKILLED NURSING FACILITY, HE WAS HAVING EPISODES OF CONFUSION. AFTER BEING DISCHARGED, THE CONFUSION CONTINUED. I INFORMED HIS PRIMARY PHYSICIAN NURSE OF OCCURRENCE. SHE STATED THAT TRAMADOL HAS BEEN KNOWN TO CAUSE CONFUSION IN ELDERLY PTS. MY FATHER BECAME CONFUSED PER PRIMARY PHYSICIAN AND PULLED OUT HIS CATHETER. LATER A FRACTURED SPINE WAS DISCOVERED. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2013. WHY WAS THE PERSON USING THE PRODUCT (SUCH AS, WHAT CONDITION WAS IT SUPPOSED TO TREAT: URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12596 FOLEY CATHETER FOLEY CATHETER EZL UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H