BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 2903257 · Received January 2, 2013

    Report

    Report Number
    2183959-2013-00005
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFO: CATALOG #: 72402106, (B)(4) #: 601926004, EXPIRATION DATE: 07/08/2014, MFR DATE: 07/2009; CATALOG #: 72402287, SERIAL #: (B)(4), EXPIRATION DATE: 05/27/2014, MFR DATE: 06/2009. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO FLUID LOSS. A NEW DEVICE WAS IMPLANTED ON THE SAME DAY AS THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R