BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 3143002 · Received May 30, 2013

    Report

    Report Number
    2183959-2013-00850
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. ADD'L INFO: CATALOG NUMBER: 72402106, LOT/SERIAL NUMBER: (B)(4), EXPIRATION DATE: 12/08/2010. CATALOG NUMBER: 72402287, LOT/SERIAL NUMBER: (B)(4), EXPIRATION DATE: 01/12/2012. DEVICE MANUFACTURE DATES: CUFF: 01/01/2003, BALLOON: 12/01/2005, PUMP: 01/01/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HER ARTIFICIAL BOWEL SPHINCTER (ABS) EXPLANTED DUE TO A PUMP MALFUNCTION AND INCONTINENCE. THE PATIENT HAD A NEW ABS IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238268 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC. 363824003

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention