MAUDE Adverse Event Report: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Vertigo (2134); Sore Throat (2396); Sleep Dysfunction (2517)

Event Date 05/08/2023

Event Type  Injury  

Event Description

A reporter stated over the phone that she had an mri with contrast injection and experienced an adverse effects.She said her cardiologist ordered the mri with contrast, protocol tc99m-1, when he was not supposed to.She said after she had the mri test, she started having rash, scratchy throat, itchy and dry skin, vertigo and sleep problems.

• Brand Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 17869650
• MDR Text Key: 324976949
• Report Number: MW5146504
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 66 KG