BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY

    MDR report key: 696859 · Received April 5, 2006

    Report

    Report Number
    3004209178-2006-00549
    Event Type
    Other
    Date Received
    April 5, 2006
    Date of Event
    July 22, 2005
    Report Date
    March 27, 2006
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS ENTIRE IPF SYSTEM REMOVED IN 2005 DUE TO NON HEALING SKIN ABCESS. THE DEVICE WAS REMOVED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY IPG LGW MDT PUERTO RICO OPERATIONS CO., MEDREL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other