BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 622803 · Received July 27, 2005

    Report

    Report Number
    2125050-2005-00267
    Event Type
    Injury
    Date Received
    July 27, 2005
    Date of Event
    June 14, 2005
    Report Date
    June 27, 2005
    Manufacturer
    MENTOR CORPORATION - MINNESOTA DIVISI
    Product Code
    FWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THE TUBING TO THE RESERVOIR WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS FWH MENTOR CORPORATION - MINNESOTA DIVISI NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R