HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN L

Additional Manufacturer Narrative

INCIDENT ONE 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. THIS 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 AN ITCHY RASH LOCATED ACROSS THE TOPS OF THEIR HANDS. THE CONDITION SPREAD UPWARD TO THE ELBOWS. THE STAFF MEMBER BELIEVES THE REACTION IS RELATED TO THE SURGICAL GOWNS INTRODUCED. INITIAL SYMPTOMS BEGAN ON THE TOPS OF THE HANDS AND LATER EXTENDED TO THE ELBOWS. THE STAFF MEMBER SOUGHT MEDICAL EVALUATION AND RECEIVED LONG-TERM STEROID CREAM TREATMENT. STAFF MEMBER WAS PROVIDED A SUBSTITUTE GOWN. ALLERGY TESTING WAS CONDUCTED. DUPIXENT WAS PRESCRIBED AS PART OF THE TREATMENT PLAN. THE STAFF MEMBER HAS COMPLETED ALLERGY TESTING.