BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4121546 · Received July 29, 2014

    Report

    Report Number
    1049092-2014-00350
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION, AS NONE OF THE DEVICES ATTEMPTED TO USE REACHED THE PT OR WERE INSERTED INTO PTS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. PLEASE NOTE: THERE ARE THREE (3) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER TWO (2) CASES. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. REPORTED TO FDA ON (B)(4) 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH BATCH 4K01645 WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES, INCLUDING NON-CONFORMANCES/DEVIATIONS, WERE FOUND. A VISUAL INSPECTION OF THE PHOTOGRAPH WAS CONDUCTED; HOWEVER THIS IS A KNOWN COMPLAINT ISSUE WHICH HAS BEEN INVESTIGATED. THE PHOTOGRAPH WAS EVALUATED TO DETERMINE THAT IT WAS INDEED CONVATEC PRODUCT; THE ASSOCIATED INVESTIGATION SUPPORTS THAT SKIN COMPLICATIONS MAY OCCUR WITH THE USE OF OSTOMY PRODUCTS. NO ADDITIONAL EVALUATION OF THE PHOTOGRAPH IS REQUIRED. THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN TESTING THE BALLOON PRIOR TO INSERTION, THE NURSE WAS UNABLE TO WITHDRAW THE WATER THAT WAS INSTILLED INTO THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442689 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1