BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER WITH BIOGLIDE, NO SLITS

    MDR report key: 192051 · Received October 7, 1998

    Report

    Report Number
    2021898-1998-00104
    Event Type
    Injury
    Date Received
    October 7, 1998
    Report Date
    September 3, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS REVISED DUE TO BLOCKAGE. WHEN EXPLANTED, IT APPEARED THAT THE BIOGLIDE ON THE CATHETER WAS PEELING. THIS OCCURRED WITH APPROX SIX CATHETERS (MFR REPORT 2021898-1998-00103 - 2021898-1998-00108). THE DR USES AN IODINE TINCTURE PRE-SOAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL CATHETER WITH BIOGLIDE, NO SLITS Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention