BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ACTICON NEOSPHINCTER

    MDR report key: 4201897 · Received October 27, 2014

    Report

    Report Number
    2183959-2014-00475
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    MIP
    PMA / PMN Number
    P010020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IN THE ORDER OF CUFF, BALLOON, PUMP. CATALOG #: 72401980, 72402106, 72402287. EXPIRATION DATE: 7/31/2001, 6/30/2001, 11/30/2001. SERIAL #: (B)(4). DEVICE MANUFACTURE DATE: 07/19/1996, 07/19/1996, 11/18/1996.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTICON BOWEL SPHINCTER WAS REMOVED DUE TO FLUID LOSS. ANOTHER ACTICON DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682904 AMS ACTICON NEOSPHINCTER IMPLANTED FECAL INCONTINENCE DEVICE MIP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R