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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Projectile incident in mri.Pt had a metal pill holder in bra.Came out of bra in mri and hit top of head coil breaking off 2 pieces.No harm to the patient.

• Brand Name: MRI MACHINE
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 24445234
• Report Number: MW5184416
• Device Sequence Number: 15944927
• Product Code: LNH
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White