BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURTGITEK UNIFLATE PENILE IMPLANT

    MDR report key: 36826 · Received September 3, 1996

    Report

    Report Number
    2182596-1996-00012
    Event Type
    Malfunction
    Date Received
    September 3, 1996
    Report Date
    August 29, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    MALFUNCTION OF PENILE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURTGITEK UNIFLATE PENILE IMPLANT Implant TWO-PART INFLATABLE PENILE IMPLANT FHW MEDICAL ENGINEERING CORP. 0251000 UF507-89G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention