BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1962708 · Received January 11, 2011

    Report

    Report Number
    2243969-2011-00003
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    June 10, 2009
    Report Date
    December 14, 2010
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(6), 2011.

    Description of Event or Problem · 1

    FOUND IN A PUBLISHED ARTICLE: ARTICLE: FLEXI-SEAL FMS AE IN PUBLISHED LITERATURE: MASSEY ET AL. COLORECTAL DIS 2010 JULY; 12 (7 ONLINE): E173-4:EVENT: ISCHAEMIC TRAUMA LEADING TO ANO-VAGINAL FISTULA. (B)(6) FEMALE DIABETIC PATIENT WAS ADMITTED TO HOSPITAL WITH DIABETIC KETOACIDOSIS. SHE DEVELOPED DIARRHEA WHICH WAS MANAGED WITH FMS. AT 3-MONTHS LATER, SHE WAS ADMITTED TO THE (B)(6) WITH A 3 MONTH HISTORY OF FAECAL INCONTINENCE AND PASSAGE OF FAECES PER VIGINAM. A 2.5CM ANO-VAGINAL FISTULA WITH COMPLETE DISRUPTION OF THE ANAL SPHINKTER MECHANISM WAS FOUND. BIOPSIES FROM THE FISTULA SHOWED HISTOLOGICAL APPEARANCES CONSISTENT WITH ISCHAEMIC TRAUMA. PATIENT UNDERWENT SURGERY AND A "DEFUNCTIONING SIGMOID COLOSTOMY FOR SYMPTOMATIC CONTROL WAS FASHIONED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL FMS FECAL MANGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention