BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCARE BLADDER SYSTEM

    MDR report key: 513493 · Received January 21, 2004

    Report

    Report Number
    9617096-2004-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    January 1, 2003
    Report Date
    December 29, 2003
    Manufacturer
    FINETECH MEDICAL LTD.
    Product Code
    GZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VOCARE BLADDER SYSTEM IMPLANTABLE COMPONENTS NOT FUNCTIONING. PT SCHEDULED FOR SURGERY TO EVALUATE AND POSSIBLY REPLACE IMPLANTABLE COMPONENTS. PHYSICIAN WILL PROVIDE FURTHER INFO FOLLOWING SURGERY AND WILL RETURN DEVICE FOR EVAL IF REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE BLADDER SYSTEM ACTIVE IMPLANT - BLADDER CONTROLLER GZC FINETECH MEDICAL LTD. 1640 1105

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention