BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3C3950 - FLEXI-SEAL

    MDR report key: 11251132 · Received January 29, 2021

    Report

    Report Number
    8022978-2021-00001
    Event Type
    Injury
    Date Received
    January 29, 2021
    Report Date
    January 22, 2021
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BEING SUBMITTED TO CORRECT THE MANUFACTURING SITE WHICH WAS SUBMITTED INCORRECTLY IN THE INITIAL MDR 8022978-2021-00001, PATIENT ID (B)(6) ON JANUARY 29, 2021; THEREFORE THE INITIAL MDR 8022978-2021-00001IS BEING RETRACTED. THE CORRECT MANUFACTURER REPORT NUMBER SHOULD BE MDR 1049092-2021-00005, PATIENT ID (B)(6) AND HAS BEEN SUBMITTED ON 2/5/2021. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN FDA MEDWATCH FORM RECEIVED VIA US POSTAL MAIL THAT ": PATIENT WITH HISTORY OF SIGNIFICANT FOR STAGE II NSCLC (STAGE 2 NON-SMALL CELL LUNG CANCER) DEVELOPED COMPLEX RECTOVAGINAL, AND RECTOURETHRAL FISTULA. POTENTIALLY ATTRIBUTED TO FLEXISEAL FECAL MANAGEMENT SYSTEM IN THE SETTING OF RECENT BEVACIZUMAB USE (CHEMOTHERAPY TREATMENT). PATIENT HAD FMS (FECAL MANAGEMENT SYSTEM) PLACED FOR A TOTAL OF 10 DAYS." THERE WAS NO CONTACT INFORMATION ON THE FDA FORM THEREFORE UNABLE TO MAKE CONTACT TO OBTAIN MORE INFORMATION REGARDING THE ISSUE AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149242 L3C3950 - FLEXI-SEAL TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC 418000

    Patients

    Seq Age Sex Outcome Treatment
    1