MAUDE Adverse Event Report: PHILIPS GLOBAL BUSINESS SERVICES LLP PHILIPS FLEX MEDIUM SIZE COIL; COIL, MAGNETIC RESONANCE, SPECIALTY

Lot Number 4522-132-71354

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Patient had mri of left shoulder and left facility without any problems.Pt went to clothing store and took off his shirt and noticed small burns on his chest.Pt called us to report it and pt.Returned to our facility where the mri technician examined left side of patients chest where the small burn marks were.She then informed the patient that the burns were from the cord of the mri coil.Coil was reported to manufacturer and taken out of use.Follow up was done with the patient this morning and he stated stable if not slightly better marks on his chest.

• Brand Name: PHILIPS FLEX MEDIUM SIZE COIL
• Type of Device: COIL, MAGNETIC RESONANCE, SPECIALTY
• Manufacturer (Section D): PHILIPS GLOBAL BUSINESS SERVICES LLP
• MDR Report Key: 16529196
• MDR Text Key: 311165888
• Report Number: MW5115653
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4522-132-71354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White