BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 40436 · Received September 26, 1996

    Report

    Report Number
    2126328-1996-04468
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 15, 1996
    Product Code
    FHW
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PERFORMED WITHIN SPECIFICATIONS. TUBING WAS FUNCTIONAL. RESERVOIR HAD A WEAR LEAK.

    Description of Event or Problem · 1

    THE PUMP AND RESERVOIR WERE REMOVED FROM THE PATIENT AND REPLACED DUE TO MALFUNCTION. ADDITIONAL INFORMATION RECEIVED ON 10/08/1996 INDICATES FLUID LOSS - RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant FHW

    Patients

    Seq Age Sex Outcome Treatment
    1 *