BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ACTICON NEOSPHINCTER

    MDR report key: 4847076 · Received June 16, 2015

    Report

    Report Number
    2183959-2015-00243
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    July 28, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    MIP
    PMA / PMN Number
    P010020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BALLOON, CATALOG #: 72400024, EXPIRATION DATE: 8/11/2008, SERIAL #: (B)(4), MANUFACTURE DATE: 8/2003. PUMP, CATALOG #: 72402287, EXPIRATION DATE: 7/21/2009, SERIAL #: (B)(4), MANUFACTURE DATE: 7/2004.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HER ACTICON PUMP AND BALLOON REMOVED IN (B)(6) 2006 DUE TO INFECTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391136 AMS ACTICON NEOSPHINCTER IMPLANTED FECAL INCONTINENCE DEVICE MIP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R