BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ STAY SAFE

    MDR report key: 731163 · Received May 31, 2006

    Report

    Report Number
    731163
    Event Type
    Injury
    Date Received
    May 31, 2006
    Date of Event
    March 10, 2006
    Report Date
    May 17, 2006
    Manufacturer
    FMC
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    SC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CALLED PD NURSE 3-12-06 WITH COMPLAINT ABD PAIN + WEAKNESS, HE REPORTS THAT HIS CYCLER TUBING CAME APART IN THE AM HOURS OF 3-10-06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ STAY SAFE CYCLER TUBING FPA FMC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention IP ANTIBIOTICS TO TREAT PERITONITIS.