BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSS LABS

    MDR report key: 24867 · Received March 8, 1995

    Report

    Report Number
    24867
    Event Type
    Injury
    Date Received
    March 8, 1995
    Date of Event
    August 18, 1994
    Report Date
    January 30, 1995
    Manufacturer
    ROSS LABORATORIES
    Product Code
    FFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERNAL BUMPER FROM A P.E.G. TUBE PLACED 7/29/94 BECAME SEPERATED FROM EXTERNAL TUBE. REQUIRED ENDOSCOPIC REMOVAL.ACCORDING TO CARE GIVERS, PT PULLED ON EXTERNAL TUBE CAUSING THE SEPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS LABS FLEXIFLO #20 PEG TUBE & BUMPER FFW ROSS LABORATORIES FLEXIFLO #20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention