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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was screened for a mri and did not disclose that she had a "butt plug" inserted.She went in for the mri and when the mri was over and the tech was pulling the table out the patient started to scream.The patient stated that she felt nauseous, was in pain, and felt like she was going to pass out.An ambulance was called for this patient and she was sent to the hospital.The patient was checked out by the radiologist at the site before transport to ensure the patient was doing okay.The patient has not returned any of our calls yet to try and follow up to see how she is doing.

• Brand Name: MRI SCANNER
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 16771275
• Report Number: MW5116847
• Device Sequence Number: 12805401
• Product Code: LNH
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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
• Operator of Device: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "BUTT PLUG"
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR
• Patient Sex: Female