Report An Adverse Event

As part of our commitment to enable safe access to accountable, high-quality FMT treatments and ensure compliance with FDA safety reporting regulations, all clinical partners and investigators that utilize OpenBiome FMT material are required to report adverse events (AEs) to OpenBiome and possibly to the FDA.

If you suspect that one of your patients or study subjects experienced a serious adverse event following their FMT, please complete the following online AE report in its entirety. Upon submission, your report will go to the Patient Safety Team at OpenBiome and MMS, a contract research organization that provides support as our pharmacovigilance contractor. We will then work with you to determine any actionable steps required.

If you have any additional questions, please also contact us at safety@openbiome.org or call 617-575-2201, option 9. We are more than willing to discuss the specifics of your case in more detail.

Please provide a phone number where you can be easily reached by a member of the Clinical Assessment and Safety team to conduct an investigation of this adverse event.

Patient/Participant Information

Please do not use PHI (e.g., patient/participant's name, medical record number, social security number)
Check any that apply.
Please list all comorbidities. If none, write n/a
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

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.
Check all that apply

FMT History

(e.g., ID# XXXX-XXXX-XX OR XXXXX-XX)
(e.g., post-pylorus)

Adverse Event Information

If ongoing, leave blank and check box below.
Please describe the clinical course and any new medical conditions, procedures, or medications for each event. Please include dates.
E.g. stool, urinalysis, pathology, autopsy, laboratory, diagnostic imaging, etc.
*Specify sequelae, if applicable
Please select one
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