BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3733537 · Received March 31, 2014

    Report

    Report Number
    2243969-2014-00153
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE SERIOUS INJURY. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. BOTH POTENTIAL MFG SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO FDA ON MARCH 28, 2014 REPORTING SITE: 2243969, MFG SITE(S): 2182291, 8022978. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PT EXPERIENCED A RECTAL ULCERATION WHILE THE FLEXI-SEAL SIGNAL SYSTEM WAS IN USE. THERE IS NO INFO REGARDING THE PATIENT'S MEDICAL HISTORY OR IF A DIGITAL EXAM WAS PERFORMED PRIOR TO USE. THERE IS NO OTHER INFO AVAILABLE AT THIS TIME AND THE LOT NUMBER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189900 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention