BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFLATE

    MDR report key: 34547 · Received July 8, 1996

    Report

    Report Number
    34547
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    August 11, 1995
    Report Date
    March 6, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF SURGERY, IT WAS FOUND THAT THE PROSTHESIS WAS DEFECTIVE IN THAT THE TUBING FROM ONE OF THE CYLINDERS HAD BECOME DISCONNECTED FROM THE SCROTAL RESERVOIR/PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFLATE Implant INFLATABLE PENILE PROSTHESIS FHW MEDICAL ENGINEERING CORP. 1000 UF878-90C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention