BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI SEAL SIGNAL (FMS) SYSTEM

    MDR report key: 6087647 · Received November 8, 2016

    Report

    Report Number
    1049092-2016-00457
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A PRODUCT MALFUNCTION. BASED ON INFORMATION PROVIDED, NO PATIENT HARM OCCURRED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 8, 2016. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 THIRD PARTY MANUFACTURER: 2182291, 8022978 NOTE: THERE ARE TWO (2) MORE ASSOCIATED CASES WITH REGARDING THE REPORTED EVENT. A SEPARATE 3500A FORM HAS BEEN CREATED FOR EACH EVENT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING THAT TWO (2) PRODUCTS HAD PIN HOLES IN THE BALLOON AND WOULD NOT RETAIN WATER (DATES UNKNOWN). THOSE TWO WERE ALSO DISPOSED OF. NO PICTURES WERE TAKEN. THIS WAS A BALLOON MALFUNCTION AND NO HARM CAME TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736655 FLEXI SEAL SIGNAL (FMS) SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC. 418000

    Patients

    Seq Age Sex Outcome Treatment
    1