BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 758678 · Received September 8, 2006

    Report

    Report Number
    2125050-2006-00265
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    July 24, 2006
    Report Date
    August 7, 2006
    Manufacturer
    MENTOR CORORATION-MINNESOTA DIVISION
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE RETURN OF THE EXPLANTED COMPONENTS HAS BEEN REQUESTED. AT THIS TIME, NO RESPONSE HAS BEEN RECEIVED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, QA IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE FOR THIS OCCURRENCE. SHOULD THE DEVICE BE RECEIVED, QA WILL FILE AN ADDENDUM TO THIS REPORT IF REQUIRED.

    Description of Event or Problem · 1

    MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS FHW MENTOR CORORATION-MINNESOTA DIVISION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R