MAUDE Adverse Event Report: VIOME LIFE SCIENCES GUT INTELLIGENCE TEST SUPPLEMENTS; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Urticaria (2278)

Event Type  Injury  

Event Description

Consumer took the viome gut intelligence test which then create supplements that was created uniquely for her.While taking the supplements, she broke into hives for 8 days.When she stop taking the supplements the hives went away.

• Brand Name: GUT INTELLIGENCE TEST SUPPLEMENTS
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): VIOME LIFE SCIENCES
• MDR Report Key: 13929003
• MDR Text Key: 288115446
• Report Number: MW5108529
• Device Sequence Number: 1
• Product Code: NNK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/13/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2022
• Patient Sequence Number: 1
• Treatment: SYNTHROID; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: White