BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 2969553 · Received February 15, 2013

    Report

    Report Number
    2183959-2013-00689
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 27, 2012
    Report Date
    February 5, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON CATALOG# 72402105 - LOT 424169001 EXP. 08/08/2010 MFG. 08/2005. PUMP CATALOG # 72402287 - LOT 430867013 EXP. 10/13/2010 MFG. 10/2005. 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 PT HAD HER DEVICE REMOVED DUE TO FLUID LOSS. THE PT WAS REIMPLANTED WITH A NEW ACTICON NEOSPHINCTER DEVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67010 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC. 397559001

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R