BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI SEAL SIGNAL (FMS)

    MDR report key: 6017789 · Received October 11, 2016

    Report

    Report Number
    1049092-2016-00428
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 27, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HEIGHT (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. BASED ON INFORMATION AVAILABLE NO PRODUCT MALFUNCTION OCCURRED. INFORMATION FOR USE: PRECAUTIONS AND OBSERVATIONS CARE SHOULD BE EXERCISED IN USING THIS DEVICE IN PATIENTS WHO HAVE A TENDENCY TO BLEED FROM EITHER ANTI-COAGULANT / ANTI-PLATELET THERAPY OR UNDERLYING DISEASE. IF SIGNS OF RECTAL BLEEDING OCCUR, REMOVE THE DEVICE IMMEDIATELY AND NOTIFY A PHYSICIAN. AS WITH THE USE OF ANY RECTAL DEVICE, THE FOLLOWING ADVERSE EVENTS COULD OCCUR: A. LEAKAGE OF STOOL AROUND THE DEVICE B. RECTAL/ANAL BLEEDING DUE TO PRESSURE NECROSIS OR ULCERATION OF RECTAL OR ANAL MUCOSA C. PERI-ANAL SKIN BREAKDOWN D. TEMPORARY LOSS OF ANAL SPHINCTER MUSCLE TONE E. INFECTION F. BOWEL OBSTRUCTION G. PERFORATION OF THE BOWEL. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE WAS AVAILABLE. THEREFORE, A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THIS COMPLAINT EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR 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. SUBMITTED TO THE FDA: OCTOBER 11, 2016.

    Additional Manufacturer Narrative · 1

    PMA/510K (K112342). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS THE REPORTER PROVIDED MORE DETAILS REGARDING THE COMPLAINT EVENT. IT WAS REPORTED THAT THE DEVICE WAS PLACED FOR USE DUE TO LIQUID DIARRHEA AND PERIANAL MYCOSIS OF THE SKIN. THE PATIENT WAS HOSPITALIZED FOR FOUR (4) WEEKS PRIOR TO DEVICE PLACEMENT. THERE WAS 45ML PLACED IN THE RETENTION BALLOON OF THE DEVICE. THE PATIENT DID NOT EXPRESS ANY PAIN OR DISCOMFORT DURING USE. IT WAS ALSO STATED THAT THE PATIENT WAS RECEIVING ANTICOAGULANT THERAPY FOR 24 DAYS AND DID NOT EXHIBIT ANY BLEEDING OR BRUISING PRIOR TO DEVICE PLACEMENT. THE PATIENT EXPERIENCED A ARTERIAL BLEED WITH COAGULUM. IT WAS FURTHER REPORTED THAT THE REASON FOR THE PATIENT RECEIVING HEPARIN PERFUSION ANTICOAGULANT THERAPY WAS DUE TO PROPHYLACTIC THERAPY BY IMMOBILITY, HAEMOFILTRATION AND ATRIAL FIBRILLATION. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED DUE TO MULTI-MORBID. 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

    COMPLAINANT REPORTING THAT A PATIENT EXPERIENCED RECTAL BLEEDING WHICH OCCURRED AFTER FIVE (5) DAYS OF DEVICE USAGE. THE RECTAL CAVITY WAS TAMPONADED. THE BLEEDING WAS SO SEVERE THAT THE PATIENT RECEIVED TWO (2) BLOOD TRANSFUSIONS AND THE PATIENT HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DIAGNOSED WITH ANAL ECZEMA AND PROCTITIS AFTER A PROCTOSCOPY (DATE UNKNOWN) WAS PERFORMED. THE USE OF THE DEVICE WAS STOPPED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669079 FLEXI SEAL SIGNAL (FMS) TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC. 418000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R