BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZASSI RECTAL TUBE

    MDR report key: 971236 · Received April 27, 2006

    Report

    Report Number
    971236
    Event Type
    Injury
    Date Received
    April 27, 2006
    Date of Event
    January 28, 2006
    Report Date
    March 23, 2006
    Manufacturer
    ZASSI MEDICAL EVOLUTIONS, BOWEL MANAGEMENT SYSTEMS
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR EVAL/TREATMENT OF SUDDEN ONSET LEFT SIDED WEAKNESS AND SLURRED SPEECH. LATER REQUIRED TUBE FEEDINGS AND DEVELOPED PERSISTENT DIARRHEA. ZASSI RECTAL TUB PLACED IN 2006. UPON REMOVAL TWO DAYS LATER, THE TUBE SEPARATED FROM THE PLASTIC RING/INTRALUMENAL BALLOON ASSEMBLY. PHYSICIAN REMOVE RETAINED BALLOON ASSEMBLY USING HEMOSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZASSI RECTAL TUBE RECTAL TUBE KNT ZASSI MEDICAL EVOLUTIONS, BOWEL MANAGEMENT SYSTEMS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention