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

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

Patient Problems Nausea (1970); Pain (1994)

Event Date 04/07/2023

Event Type  Injury  

Event 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
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 16771275
• MDR Text Key: 313677601
• Report Number: MW5116847
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Patient Sequence Number: 1
• Treatment: "BUTT PLUG"
• Patient Outcome(s): Hospitalization
• Patient Age: 22 YR
• Patient Sex: Female