BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS MEDICAL CARE

    MDR report key: 181107 · Received August 3, 1998

    Report

    Report Number
    181107
    Event Type
    Injury
    Date Received
    August 3, 1998
    Date of Event
    June 30, 1998
    Report Date
    July 8, 1998
    Manufacturer
    FMC
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TREATMENT INITIATED INCIDENT DEVELOPED CHEST PAIN V HYPOTENSION AT 1 1/2 HRS. PT TOOK OWN NITROGLYCERIN 1 HR LATER DEVELOPED SEVERE QUESTIONABLE CHEST PAIN SEEN BY DR AT UNIT SENT TO ER VIA ALL AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS MEDICAL CARE IPM FII FMC 2008 E. *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R