BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 1910181 · Received November 18, 2010

    Report

    Report Number
    2183959-2010-00429
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO IS SUFFICIENTLY INCLUDED IN OUR LABELING AND RISK DOCUMENTATION. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. INFO FROM THE JOURNAL OF SURGERY; NO ADD'L INFO AVAILABLE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. JOURNAL OF SURGERY (ONLINE VERSION ISSN 0718-4026), DOI 10.4067/S0718-40262009000400008, DR. OCARA MISAEL, GINO CASELLI, CASELLI BRUNO, CLAUDIO BENAVIDES, LAURA FLORES.

    Description of Event or Problem · 1

    SINCE IMPLANTATION OF ABS DEVICE, PT HAS HAD 2 EPISODES OF CONSTIPATION WITH AN EPISODE OF FECAL IMPACTION AT TWO YRS. THE JOURNAL ARTICLE INDICATED THAT A (B)(6), WOMAN, WAS HOSPITALIZED WITH SEVERE ANORECTAL TRAUMA WITH FECAL INCONTINENCE. PT INDICATED AN IMPROVEMENT IN FECAL INCONTINENCE WITH ABS IMPLANT. THE PT HAS HAD 2 EVENTS OF CONSTIPATION AND ONE EVENT OF FECAL IMPACTION AT 2 YRS. NO ADD'L INFO WAS PROVIDED IN THE ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability