HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN L
Received Apr 23, 2026 · Event occurred Feb 21, 2025
Report 9680646-2026-00003 · MDR key 24968825
Device
Generic name
Surgical Gowns
Manufacturer
O&m Halyard, Inc.Model number
41733Catalog number
41733
Lot number
AH5330TC5
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
INCIDENT THREE OF ELEVEN. THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. THE PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
Description of Event or Problem
THE STAFF MEMBER REPORTED A RASH EXTENDING FROM THE HANDS TO THE ELBOWS. THE COMPLAINT REPORT REFERENCED POSSIBLE INVOLVEMENT OF AVAGARD SCRUB. A SUBSTITUTE GOWN WAS ISSUED, AND THE STAFF MEMBER IS CURRENTLY USING A CARDINAL GOWN. NO MEDICAL TREATMENT WAS SOUGHT, AND NO ALLERGY TESTING HAS BEEN PERFORMED.