BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE INTERMITTENT URINARY CATHETER

    MDR report key: 1173363 · Received September 24, 2008

    Report

    Report Number
    1055889-2008-00001
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    APOGEE MEDICAL, LLC
    Product Code
    KOD
    PMA / PMN Number
    992137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE ADVERSE EVENT REFLECTS THE EVENT AS REPORTED TO APOGEE MEDICAL, LLC; APOGEE MEDICAL, LLC DOES NOT HAVE ANY INDEPENDENT KNOWLEDGE OR CONFIRMATION OF THE EVENT. THIS REPORT OR INFO SUBMITTED DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, APOGEE MEDICAL, LLC, ITS PARENT COMPANY OR THEIR RESPECTIVE EMPLOYEE(S) CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    CAREGIVER OF THE PT, REPORTEDLY ATTEMPTED TO CATHETERIZE THE PT USING AN APOGEE INTERMITTENT CATHETER (CATALOG# 1050, LOT# 6016) IN THE DARK. IT WAS REPORTED THAT AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE CAREGIVER NOTICED THAT THE PT WAS BLEEDING FROM THE URETHRA. UPON REMOVAL OF THE CATHETER, THE CAREGIVER REPORTED THAT THE TIP OF THE CATHETER WAS CUT AT A SHARP ANGLE. THE PT WAS REPORTEDLY TAKEN TO THE HOSPITAL WITH A TEMPERATURE. IT WAS LATER REPORTED THAT THE PT WAS HOSPITALIZED THREE DAYS IN 2008. THE PT REPORTEDLY RECEIVED ANTIBIOTICS AND REQUIRED A TEMPORARY SUPRAPUBIC CATHETER TO BE PUT IN ORDER TO ALLOW THE URETHRA TO HEAL. THE CAREGIVERS HAVE SINCE REPORTED THAT THE SUPRAPUBIC CATHETER HAS BEEN REMOVED AND THE PT IS BEING SUCCESSFULLY CATHETERIZED IN THE NORMAL MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APOGEE INTERMITTENT URINARY CATHETER INTERMITTENT URINARY CATHETER KOD APOGEE MEDICAL, LLC 1050 6016

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R