BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 2850589 · Received November 16, 2012

    Report

    Report Number
    2183959-2012-03011
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    April 12, 2012
    Report Date
    November 5, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE CUFF REPLACED AS THE "CUFF WAS NOT CLOSED." THE PATIENT EXPERIENCED RECURRING INCONTINENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R