BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITEK UNIFLATE PENILE IMPLANT

    MDR report key: 36817 · Received September 3, 1996

    Report

    Report Number
    2182596-1996-00006
    Event Type
    Malfunction
    Date Received
    September 3, 1996
    Report Date
    August 31, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    ALLEGED MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK UNIFLATE PENILE IMPLANT Implant TWO-PART INTRACORRPRAL PENILE IMPLANT FHW MEDICAL ENGINEERING CORP. 0259100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention