BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 4439974 · Received January 21, 2015

    Report

    Report Number
    1049092-2015-00038
    Event Type
    Death
    Date Received
    January 21, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 8, 2015
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A DEATH. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL PATIENT AND EVENT DETAILS HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE NURSE REPORTS THE PATIENT WAS INITIALLY ADMITTED TO HOSPITAL WITH SEPTIC SHOCK ON (B)(6) 2014 A FLEXI-SEAL FMS WAS PLACED FOR 'LOOSE STOOL'. THE NURSE FURTHER REPORTS THE FLEXI-SEAL FMS WAS REPLACED ON (B)(6) 2014, FOR AN UNKNOWN REASON; ON (B)(6) 2014 THE PATIENT HAD PERI-RECTAL BLEEDING, ON (B)(6) 2014 THE FLEXI-SEAL FMS WAS REMOVED, WAS NOT REPLACED. THE PATIENT HAD A COLONOSCOPY WHICH REVEALED AN INTERNAL PERI-RECTAL ULCER WHERE THE FLEXI-SEAL FMS RETENTION BALLOON WAS IN CONTACT 'WITH THE PERI-RECTAL AREA'. THE PHYSICIAN REPORTS THE PATIENT HAD BROWN BLOOD TINGED STOOL FOLLOWING THE COLONOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50516 FLEXI-SEAL SIGNAL FMS GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 418000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R