BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 2400729 · Received December 29, 2011

    Report

    Report Number
    1417592-2011-00066
    Event Type
    Death
    Date Received
    December 29, 2011
    Report Date
    December 28, 2011
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT SEVERAL MONTHS AGO AN ELDERLY PT WAS ADMITTED TO THE HOSP FROM A NURSING HOME WITH SHORTNESS OF BREATH AND ABDOMINAL PAIN. SHE HAD AN INDWELLING LATEX CATHETER IN PLACE. UPON ADMISSION, THE CATHETER WAS REPLACED WITH A SILICONE CATHETER. DURING THE NEXT 12-13 DAYS, THE PT'S CONDITION WORSENED AND SHE SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS RULED TO BE SEPSIS. THE BLADDER WAS FOUND TO BE PERFORATED. THE ACCOUNT REPORTED THAT AN INTERNAL INVESTIGATION DID NOT IDENTIFY THE CAUSE OF THE BLADDER PERFORATION. THE CATHETER WAS NOT RETAINED FOR EVAL BUT THE ACCOUNT STATED THEY DID NOT OBSERVE ANY ABNORMALITIES UPON INSERTION. NO LOT NUMBER OR PHOTOS WERE PROVIDED. THERE IS NO INFO INDICATING THE CATHETER CAUSED OR CONTRIBUTED TO THE BLADDER PERFORATION. WE HAVE NO OTHER SIMILAR REPORTS FILED FOR THIS DEVICE. HOWEVER, DUE TO THE REPORTED INCIDENT AND SUBSEQUENT DEATH OF THE PT, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE HOSPITAL STATED THAT A PREVIOUS INCIDENT OCCURRED THAT HAD NOT PREVIOUSLY BEEN REPORTED TO US. A PT'S BLADDER WAS FOUND TO BE PERFORATED AFTER A CATHETER HAD BEEN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE FOLEY CATHETER NONE KOD MEDLINE INDUSTRIES, INC. DYND160816 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O