BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN ACCUFLO

    MDR report key: 13292 · Received May 17, 1994

    Report

    Report Number
    MW1002010
    Event Type
    Injury
    Date Received
    May 17, 1994
    Date of Event
    April 5, 1994
    Report Date
    May 4, 1994
    Manufacturer
    JOHNSON & JOHNSON PRODUCTS
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A 2 1/2-YR-OLD WITH SHUNT DEPENDENT HYDROCEPHALUS, ASSOCIATED WITH DOWN'S AND A POSTERIOR FOSSA DEFECT. THE REGION HAD BEEN SHUNTED IN 9/92. HE PRESENTED WITH A SUBCUTANEOUS CSF COLLECTION. THE CT DEMONSTRATED SMALL VENTRICLES BUT X-RAYS DEMONSTRATED FRACTURE OF THE PERITONEAL CATHETER AND THE VENTRICULAR CATHETER AT THE JUNCTION WITH THE VALVE RESERVOIR. THIS WAS CONFIRMED AT THE TIME OF SURGERY WITH REPLACEMENT WITH A LOW PRESSURE SYSTEM. BLOOD LOSS IS NEGLIGIBLE. THE PT TOLERATED THE PROCEDURE WELL. (ALSO SEE 1002011.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN ACCUFLO Implant ACCUFLO DEVICE JXG JOHNSON & JOHNSON PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Other| R