BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 2879947 · Received December 12, 2012

    Report

    Report Number
    2183959-2012-03256
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L: CATALOG# 72402106, 72402287; SN # (B)(4); EXPIRATION DATES: 02/28/2013, 07/11/2013; MANUFACTURE DATES: 02/2008, 07/2008. THE RETURNED AND EVALUATED BALLOON AND PUMP PERFORMED WITHIN SPECS. THE CUFF WAS LEAKING FROM WEAR AT A FOLD. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO PT DISSATISFACTION, FLUID LOSS, AND THE DEVICE WAS DEACTIVATING SPONTANEOUSLY.

    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 73 YR Hospitalization| R