BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZASSI BOWEL MANAGEMENT SYSTEM

    MDR report key: 1386444 · Received May 14, 2009

    Report

    Report Number
    1480288-2009-00003
    Event Type
    Other
    Date Received
    May 14, 2009
    Date of Event
    March 8, 2009
    Report Date
    May 12, 2009
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KNT
    PMA / PMN Number
    K023344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE COLONOSCOPY REVEALED LOWER GI BLEED SECONDARY TO ANAL CANAL AND DISTAL RECTAL ULCERATION. THE BLEEDING STOPPED ON ITS OWN AND ANNUSOL-HC RECTAL SUPPOSITORIES AT HS WERE PRESCRIBED. THERE WERE NO FURTHER ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, A RECTAL CATHETER (NOT ZASSI) WAS INSERTED INTO A PATIENT SUFFERING FROM PARTIAL THICKNESS BURNS TO THE BACK, BILATERAL BUTTOCKS AND FLANK. ON (B)(6) 2009, THE PATIENT WAS NOTED TO HAVE EXPELLED THE RECTAL CATHETER. A ZASSI BOWEL MANAGEMENT SYSTEM WAS THEN INSERTED THE SAME DAY. ON (B)(6) 2009, THE ZASSI BOWEL MANAGEMENT SYSTEM (RECTAL CATHETER) WAS NOTED TO BE CUT OUT THE PATIENT (EXPELLED), AND IT WAS NOT REINSERTED. ON (B)(6) 2009, RECTAL BLEEDING WAS NOTED TO HAVE DEVELOPED. A COLONOSCOPY WAS REQUIRED AND REVEALED ULCERATION IN THE ANAL CANAL WITH ERYTHEMA AND SOME SLIGHT CLOTS. AT THE TIME OF THE COLONOSCOPY, THERE WAS NO ACTIVE BLEEDING NOTED AND NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZASSI BOWEL MANAGEMENT SYSTEM ZASSI KNT HOLLISTER INCORPORATED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other