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

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/14/2022

Event Type  Injury  

Event Description

Patient received thermal burns during mri due to a mocean tech polo with x-static silver fiber.Redness and raised areas were seen on the inside of both arms.Fda safety report id #(b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15825740
• MDR Text Key: 304097158
• Report Number: MW5113369
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 140 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White