Name of Reporting Individual * * Institution * * Institutional Address * * Alternate Phone E-mail Address * * Alternate Email Occupation * * Select: Administrator/Supervisor Nurse Nurse Practitioner Parmacist Physician Physician Assistant Risk Manager Other Healthcare Professional Non-Healthcare Professional Patient/Participant Information Age Weight Race
Check any that apply.
Pre-Existing Medical Conditions
Please list all comorbidities. If none, write n/a
List of Medications Prior to investigational FMT (including Anti-CDI medications)
Please list names of all medications. If none, write n/a
Please list all known drug allergies. If none, write n/a.
Clostridium difficile infection (CDI) History Modified Horn Index Pre- investigational FMT
Please select one
Check any that apply and describe below
Please scroll down to the bottom of the page for detailed descriptions of CDI severity.
Select Mild Moderate Severe Severe-Complicated Disease Type
Check all that apply
Investigational FMT History Was an investigational FMT performed? Was the investigational FMT performed under an IND? If yes, please provide the IND number and study name. Treating MD (if different from individual completing this survey) Treating MD's Phone Number Treating MD's Email Address Route of investigational FMT Administration Select Colonoscopy Sigmoidoscopy Nasoenteric Delivery Upper Endoscopy Capsule Enema Other If other, please describe here Any problems with the procedure or patient during investigational FMT? If yes, please describe: Was the patient discharged post-investigational FMT? If yes, please list discharge date, patient disposition at discharge, and location where discharged to Adverse Event Information Please provide the adverse event terms * * Please describe the adverse event in detail * *
Please describe the clinical course and any new medical conditions, procedures, or medications for each event. Please include dates.
Please describe the patient's current disposition: * * In your opinion, was the adverse event attributable to the investigational FMT material? * * Please explain the rationale for this opinion * * Specify
*Specify sequelae, if applicable
Was the adverse event unexpected? * * Was the adverse event serious? * *
Please select one
Not serious Death (Please report if you suspect that the death was an outcome of the adverse event) Life-threatening (Please report if you suspect that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient) Hospitalization, initial or prolonged (Please report if admission to the hospital or prolongation of hospitalization was a result of the adverse event) Disability or Permanent Damage (Please report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life) Required Intervention to Prevent Permanent Impairment or Damage (Please report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product) Congenital Anomaly/Birth Defect (Please report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child) Adverse Event of Special Interest Other Serious - Important Medical Events (Please report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes) If you selected "Other Serious", please provide more details to describe why the event was considered serious. Was the MedWatch 3500 Report sent to the FDA? * *