BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 3302902 · Received August 16, 2013

    Report

    Report Number
    2183959-2013-00951
    Event Type
    Injury
    Date Received
    August 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    July 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. BALLOON - CATALOG #72402105, SERIAL # (B)(4), EXPIRATION DATE 08/05/2009, MANUFACTURE DATE 08/2004. PUMP - CATALOG #72402287, SERIAL # (B)(4), EXPIRATION DATE 07/21/2009, MANUFACTURE DATE 07/2004.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD HIS ACTICON NEOSPHINCTER REPLACED ON (B)(6) 2013 DUE TO FLUID LOSS. NO PT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396561 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R