MRI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for MRI manufactured by Unknown.

Event Text Entries

[184480271] Told the attendant i was allergic to nickel before undergoing an mri. The next morning my neck was profusely enlarged on the left side. Four days later i had what felt like a hammer hit the back of my head while driving. The emergency room in (b)(6) sent me by ambulance to (b)(6) hospital in (b)(6). There i was diagnosed with lymphoma large b cell. I have had 3 treatments for it. My eye doctor ordered the mri because of blurred vision. (b)(6) 2019 (b)(6) hospital, (b)(6). Had an mri done and told them when asked "was i allergic to anything". Nickel. The next morning my neck on the left side was swollen as if i had swallowed a hot bun and become logged in my throat. Wed. (b)(6) - i felt a blow to the back of my head and a terrible headache while driving - went to emergency center sent to emergency rm at hospital - taken to (b)(6) medical ctr by ambulance that night. Diagnosed with lymphoma the next day - under went chemo (3 treatments). Relevant tests/laboratory data: mri, date: (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093861
• MDR Report Key: 9859924
• Date Received: 2020-03-19
• Date of Event: 2019-09-07
• Date Added to Maude: 2020-03-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MRI
• Generic Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Product Code: LNH
• Date Received: 2020-03-19
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2020-03-19