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

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2020

Event Type  malfunction  

Event Description

I was told that i could wear my facemask (which contains a metal noseclip) during my mri.I am concerned that it affected the mri results.I am concerned that my mri, which was a 6 month followup to dcis breast cancer lumpectomy and radiation, may have been inaccurate because i wore my face mask.I was advised to have another one in 6 months.Mfr: i don't know.Fda safety report id# (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 14015114
• MDR Text Key: 288698010
• Report Number: MW5108765
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG