BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL

    MDR report key: 17350480 · Received July 19, 2023

    Report

    Report Number
    1049092-2023-00224
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Report Date
    July 11, 2023
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 . MANUFACTURING SITE: 8022978.

    Additional Manufacturer Narrative · 0

    E1: PATIENT COUNTRY: UNITED KINGDOM. AFFILIATION: (B)(6) HOSPITAL (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE SERIOUS INJURY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 8022978.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED "THE PATIENT USED THE ITEM FROM (B)(6) 2023 TO (B)(6) 2023 - ON THE (B)(6) 2023 THE PATIENT WAS REPORTED TO HAVE AN ANAL TEAR. THE PRODUCT WAS REMOVED AND A FURTHER BAG INSERTED. THE TEAR WAS REVIEWED BY SURGEONS AND THEY ADVISED IT WOULD BE LIKELY THE PATIENT WOULD NEED A STOMA DUE TO THE TEAR, THE PATIENT PASSED AWAY SO UNFORTUNATELY THEY COULD NOT ASSESS WHETHER THE TEAR WOULD HEAL." PER ADDITIONAL INFORMATION RECEIVED, IT WAS UNCLEAR IF A RECTAL EXAM WAS PERFORMED PRIOR TO PLACEMENT. IT WAS FURTHER STATED "WE ALWAYS PUT 45 MLS IN THE BALLOON AS SPECIFIED BY THE MANUFACTURER AND THE REASON IT WENT IN WAS THE PATIENT HAD LOOSE STOOLS AND HER SKIN WAS VULNERABLE AND BREAKING DOWN. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS SEPTICAEMIA AND IMMUNOSUPPRESSION SECONDARY TO TREATMENT FOR RHEUMATOID ARTHRITIS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36536 FLEXI-SEAL SIGNAL TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC 418000 22FM0409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown