MRI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-31 for MRI manufactured by Unk.

Event Text Entries

[132332179] My doctor at (b)(6) did a i4 i5 s1 fusion laminectomy. I had remembered the doctor (b)(6) telling us no mri's ever after the fusion. However they kept telling me they didn't say that and the mri was safe i had titanium and there is no reason to not do the mri, they told me this 3 times and i agreed to go do the mri on (b)(6) 2018, so i would be able to get some pain relief. I went in to the mri at (b)(6) hospital imaging in (b)(6). It is an open mri with a coil, the 1st test was without contrast and was burning very painful. The 2nd test with contrast was just as painful and warm which i did expect the warm with the contrast part. I told the tech he said the pain was from the table being so stiff, it took a lot for me to even be able to get off the mri table. I was in severe pain all day and called the hospital, spoke with (b)(6) the manager in imaging, they talked to my doctor at (b)(6) and nobody is doing anything. I'm still in ten times more pain than when i walked in for the mri, and now am scared to death of what this did to me if the doctor had put metal in my back during the original surgery. Fusion laminectomy i4 i5 s1 from (b)(6) at (b)(6) in (b)(6) 2009.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082749
• MDR Report Key: 8208740
• Date Received: 2018-12-31
• Date of Report: 2018-12-27
• Date of Event: 2018-12-19
• Date Added to Maude: 2019-01-02
• 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: 0

Device Sequence Number: 1

• Brand Name: MRI
• Generic Name: COIL, MAGNETIC RESONANCE SPECIALITY
• Product Code: MOS
• Date Received: 2018-12-31
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 2

• Brand Name: CONTRAST
• Generic Name: MEDIUM CONTRAST, RADIOLOGIC
• Product Code: KTA
• Date Received: 2018-12-31
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-12-31