BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 725524 · Received June 14, 2006

    Report

    Report Number
    2125050-2006-00194
    Event Type
    Injury
    Date Received
    June 14, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 15, 2006
    Manufacturer
    MENTOR CORP - MINNESOTA DIVISION
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL IS PENDING THE DECONTAMINATION OF THE COMPONENT(S). AN EVAL WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTED COMPLAINT, THERE WAS AUTOINFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS FHW MENTOR CORP - MINNESOTA DIVISION 9820I E90111

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R