An FDA MAUDE report describes a metal pill holder that a patient had inside her bra during an MRI examination. According to the narrative, the object was drawn out of the clothing and hit the top of the head coil, breaking off two pieces.
What the report actually says
The event description explicitly states that the patient was not harmed. The MAUDE entry is nevertheless classified under “Serious Injury.” The public record does not reconcile that classification with the narrative. It would be misleading to describe this as a confirmed patient injury.
What this case highlights
The metal object was not an obvious piece of clinical equipment. It was concealed in clothing. This illustrates why MR safety screening must address objects carried by patients as well as implanted devices and items used by staff. Screening and clothing procedures should follow the site's approved MR safety policy.
The record is a reported event, not a completed independent accident investigation. It does not establish how the object was missed during screening or whether a specific process failure occurred.
Original source
View the FDA MAUDE report ↗MAUDE is a reporting database. A report alone does not establish causation or event rates.