MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ECHELON OVAL; MAGNETIC RESONANCE DIAGNOSTIC DEVICE.

Model Number N/A

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

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 03/18/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, fujifilm healthcare americas corporation (formerly hitachi healthcare americas corporation) received a complaint regarding echelon oval mri.The site reported that a patient received a hip mri on (b)(6) 2021 and stated after the scan that he had received two burns on his right and left inner thighs the size of a quarter.The patient reported that the redness was less at the end of the day (day of exam) but there were pin head sized blisters on both legs in that area (3 on right, 2 on left) that evening.The next day (b)(6) he stated the blisters were scabbed over and improving, and said he was ok.Patient did not receive any medical intervention for the burns management.During a retrospective review, it was discovered that the manufacturer had assessed this event as ae leading to serious injury; therefore an importer's mdr is being submitted.

• Brand Name: ECHELON OVAL
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE.
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 704; JA 277-0704
• MDR Report Key: 13688518
• MDR Text Key: 291285603
• Report Number: 1528028-2022-00010
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/07/2022

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 Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2021
• Device Age: 7 YR
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 111 KG