BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 501635 · Received December 4, 2003

    Report

    Report Number
    3001587388-2003-00023
    Event Type
    Other
    Date Received
    December 4, 2003
    Date of Event
    June 2, 2003
    Report Date
    December 4, 2003
    Manufacturer
    SOPHYSA
    Product Code
    GBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION OF A SOPHYSA SHUNT IN 1999 INCLUDING A SOPHY SM8 ADJUSTABLE VALVE, A VENTRICULAR CATHETER WITH LEROY RESERVOIR (CAT. #PL06) AND PERITONEAL CATHETER (CAT. #B905S). IN MAY 2003, THE NEUROSURGEON NOTED THAT: I) THE PERITONEAL CATHETER WAS CUT NEAR FROM THE OUTSIDE CONNECTOR OF THE VALVE; II) THE PERITONEAL CATHETER FELL DOWN INTO THE PERITONEUM. A REVISION OF THE PERITONEAL CATHETER WAS DONE IN 2003 AND THE CUT-AND-FELL-DOWN CATHETER HARDLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PERITONEAL CATHETER GBW SOPHYSA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization