MAUDE Adverse Event Report: FONAR CORPORATION FONAR INDOMITABLE AKA UPRIGHT¿ MRI; MAGNETIC RESONANCE IMAGING SCANNER

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

Patient Problems Burning Sensation (2146); Unspecified Tissue Injury (4559)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

At this time the patient has refused to provide the information as to determine the extent of her injury, if we receive additional information we will update the report.

Event Description

It was reported that on (b)(6) 2022 a patient who had been scanned on (b)(6) 2022 reported that she "feels burnt on her arms, back and eyes".The patient also stated that there was no redness, "just feels burnt".The patient later reported that she went to an emergency room and was told that she had tissue damage on both arms.We requested a copy of the er report, but the patient did not want to provide it or any additional information that was requested.

• Brand Name: FONAR INDOMITABLE AKA UPRIGHT¿ MRI
• Type of Device: MAGNETIC RESONANCE IMAGING SCANNER
• Manufacturer (Section D): FONAR CORPORATION; 110 marcus drive; melville NY 11747 4292
• Manufacturer (Section G): FONAR CORPORATION; 110 marcus drive; melville NY 11747 4292
• Manufacturer Contact: luciano bonanni ; 110 marcus drive; melville, NY 11747-4292 ; 6316942929
• MDR Report Key: 15151889
• MDR Text Key: 297127357
• Report Number: 2432211-2022-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic