MAUDE Adverse Event Report: MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Date 03/07/2023

Event Type  Injury  

Event Description

I had a contrast mri on thursday (b)(6), 2023.Starting feeling sick on monday (b)(6).Didn't sleep as had very bad painful bloating.On tuesday (b)(6) morning, i had acute diarrhea and vomiting.Very dizzy and still very nauseous.

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 16529742
• MDR Text Key: 311218894
• Report Number: MW5115680
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LORATADINE; OCCASIONAL PARACETAMOL ; OMNISCAN CONTRAST DYE; SALBUTAMOL
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White