BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARES ANTIBIOTIC - IMPREGNATED CATHETER KIT

    MDR report key: 3080645 · Received April 9, 2013

    Report

    Report Number
    2021898-2013-00134
    Event Type
    Injury
    Date Received
    April 9, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K110560
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE STATES THAT PERFORATIONS OF THE BOWEL BY THE PERITONEAL CATHETER IS A KNOWN COMPLICATION OF PERITONEAL SHUNTING.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144714 ARES ANTIBIOTIC - IMPREGNATED CATHETER KIT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1