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

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 08/15/2019

Event Type  Injury  

Event Description

I had to have bi-lateral mars mri's done on my hips.I squeezed the emergency button during this procedure on multiple times telling the tech i was feeling like i was on fire inside.She assured me this was normal.I still feel as though my hips and lower back are burned inside my body.The heat was unbelievable.I was in there for almost two hours.I cannot tell you how much pain i am in because of this procedure.Something has got to be done about this.I saw my pchp today without resolution.At (b)(6).Fda safety report id# (b)(4).

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 8945023
• MDR Text Key: 156154299
• Report Number: MW5089450
• Device Sequence Number: 1
• Product Code: LNH
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 67