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Halyard 69702Recalls & reported problems

O&M Halyard, Inc. · HALYARD* Scrub Shirt, Large · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651697022), received between Nov 8, 2017 and Nov 8, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Electromagnetic Compatibility Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Electromagnetic Compatibility Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 8, 2017Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN MRI SCAN WHILE WEARING DISPOSABLE SCRUB PANTS. IT WAS ALLEGED THAT THE PATIENT SUSTAINED SKIN BURNS ON THE HIPS AND LEGS DURING THE MRI. PER ADDITIONAL INFORMATION RECEIVED 8 NOV 2017, THE MRI SCAN WAS OF THE CERVICAL SPINE. THE PATIENT'S SKIN AND THE MATERIAL OF THE SCRUB PANTS BECAME SCORCHED. THE PATIENT WAS BURNED ON THE INNER SIDE OF THE RIGHT BREAST. NO FURTHER INFORMATION HAS BEEN PROVIDED TO HALYARD AT THIS TIME.

    Patient problems: Burn(s)

    MAUDE report 7011158 ↗

Other ACCESSORY, SURGICAL APPAREL devices

All ACCESSORY, SURGICAL APPAREL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.