BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 442635 · Received February 13, 2003

    Report

    Report Number
    2125050-2003-00043
    Event Type
    Injury
    Date Received
    February 13, 2003
    Date of Event
    November 18, 2002
    Report Date
    January 14, 2003
    Manufacturer
    MENTOR CORP - MINNESOTA DIV
    Product Code
    FWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THE DEVICE WAS REMOVED DUE TO DEFLATION, LOSS OF FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I IPP FWH MENTOR CORP - MINNESOTA DIV NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R