Patient report to FDA describes MRI face mask burn

By Kate Madden Yee, staff writer

December 9, 2020 -- A patient report submitted in October to the U.S. Food and Drug Administration (FDA) describes a third-degree burn a patient sustained while wearing a face mask during an MRI exam.

The report was submitted to the FDA's Manufacturer and User Facility Device Experience Database (MAUDE), and it identifies the event as having occurred on September 27; the agency received it on October 6. The report does not name the device used or the healthcare provider/facility.

The MAUDE report apparently quotes the patient's comments on the exam.

"Full thickness burns to face," the statement reads. "I went in for a 3-tesla MRI scan on the cervical spine. The [tech] failed to let me undress out of my street clothes and also allowed [me to wear my face mask] which resulted in deep tissue burns across my nose, eyes, mouth, jaw, chin, neck. Basically, I have a mask burned into my face."

On December 7, the FDA issued a warning to remind healthcare providers to prevent patients from wearing masks with any metal components during an MRI exam, but it's unclear whether this particular MAUDE report was the reason for the guidance.

Copyright © 2020

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