BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERMITTENT MAGIC3

    MDR report key: 5019288 · Received August 20, 2015

    Report

    Report Number
    1018233-2015-00302
    Event Type
    Death
    Date Received
    August 20, 2015
    Report Date
    July 24, 2015
    Manufacturer
    ROCHESTER MEDICAL CORP 2130787
    Product Code
    KOD
    PMA / PMN Number
    K000723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "HOW TO PREPARE AND USE THE MAGIC 3 CATHETER. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE, DO NOT RESTERILIZE. MADE OF SILICONE ELASTOMER." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A RESULT OF USING THE DEVICE THE PATIENT EXPERIENCED AN INFECTION THAT LED TO SEPSIS, A HEART ATTACK AND DEATH. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM FOR ABDOMINAL PAIN. THROUGH EXAMINATION IT WAS DISCOVERED THE PATIENT HAD A RUPTURED BOWEL AND NEEDED EMERGENCY SURGERY TO REMOVE THE DEAD BOWEL AND PERFORM AN ILEOSTOMY. FOLLOWING THE SURGERY THE PATIENT DID NOT MAKE A FULL RECOVERY AND ENDED UP IN HEART FAILURE SECONDARY TO A MYOCARDIAL INFARCTION. THE PATIENT WAS TRANSFERRED TO INPATIENT HOSPICE WHERE SHE PASSED AWAY AS A RESULT OF HER ILLNESS ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550549 INTERMITTENT MAGIC3 MAGIC 3 KOD ROCHESTER MEDICAL CORP 2130787 73600181

    Patients

    Seq Age Sex Outcome Treatment
    1 Death