FACIAL PROTECTION RESPIRATORS

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. 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 (B)(6), AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED

Description of Event or Problem

CUSTOMER LAST WORKED (B)(6) 2023 AND GOT ON DISABILITY BECAUSE SHE IS UNABLE TO WEAR MASKS PROVIDED AT HER PLACE OF WORK. CUSTOMER STATES THERE WAS REDNESS AND IRRITATION TO FACE, UNDER EYE TO NECK. A PATCH TEST WAS PERFORMED. CUSTOMER WAS PRESCRIBED ANTIHISTAMINES, PREDNISONE, AND AN EPIPEN FOR USE IN AN ALLERGIC EMERGENCY.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. LACK OF SAMPLES AND LOT NUMBER MAKES IT DIFFICULT TO DETERMINE THE ROOT CAUSE. SINCE VISUAL AND FUNCTIONAL INSPECTIONS CANNOT BE PERFORMED, WE CANNOT CONFIRM OR REPLICATE THE INCIDENT REPORTED. COMPLAINT TREND WAS REVIEWED FOR CODE 76727 AND FAILURE MODE "REACTION" FOR THE PAST 12 MONTHS FROM JUNE 2022 TO JUNE 2023. THERE IS NO UPWARD TREND FOR THE PAST 12 MONTHS FOR ISSUE. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).