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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Urticaria (2278); Arthralgia (2355)

Event Date 06/20/2016

Event Type  Injury  

Event Description

I was given a mri with a gadolinium contrast iv to image my lower extremities in a test for kidney issues.The test instantly caused nausea, hives, and an histamine like reaction throughout my body.After the test and still continuing a year later, i have been suffering deep bone pain, lesions on my skin, and joint pain.

• Brand Name: MRI IMAGING
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 6639633
• MDR Text Key: 77633927
• Report Number: MW5070398
• Device Sequence Number: 1
• Product Code: LNH
• 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: 06/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 90