BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENVER PERITONEO - VENOUS SHUNT

    MDR report key: 879 · Received July 1, 1992

    Report

    Report Number
    879
    Event Type
    Malfunction
    Date Received
    July 1, 1992
    Date of Event
    March 12, 1992
    Report Date
    June 15, 1992
    Manufacturer
    J & J CODMAN
    Product Code
    FIQ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWEN DENVER SHUNT PLACEMENT ON 3/12/92. THE DENVER SHUNT HAD TO BE REMOVED AND REPLACED ON 3/27/92 DUE TO MALFUNCTIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER PERITONEO - VENOUS SHUNT Implant UNKNOWN FIQ J & J CODMAN UNKNOWN JG 906

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other