PFR95 PART FILT RESP

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THERE WAS NO LOT NUMBER PROVIDED BY THE REPORTER, THEREFORE, NO DHR RECORD REVIEW WAS POSSIBLE TO DETERMINE IF ANYTHING HAPPENED DURING MANUFACTURE THAT COULD POSSIBLY CONTRIBUTE TO THE ISSUE. ROOT CAUSE WAS NOT IDENTIFIED. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

A MEDWATCH REPORT (MW5116813), WAS RECEIVED ON (B)(6)2023 FROM THE FDA¿S MEDWATCH PROGRAM FOR A VIRAL INFECTION (COVID). I AM A PRIMARY CARE PHYSICIAN AND I HAD A HUGE BOX OF THESE RESPIRATORS FROM 2022 THAT I RECENTLY USED UP AND JUST STARTED USING A NEWLY ORDERED BOX WHICH I RECEIVED IN (B)(6)2023. I TOOK A RAPID COVID TEST BEFORE VISITING MY PARENTS, AND I WAS SOMEWHAT SURPRISED TO SEE A POSITIVE RESULT. MY IMMEDIATE FAMILY ALL TESTED NEGATIVE.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THERE WAS NO LOT NUMBER PROVIDED BY THE REPORTER, THEREFORE, NO DHR RECORD REVIEW WAS POSSIBLE TO DETERMINE IF ANYTHING HAPPENED DURING MANUFACTURING THAT COULD POSSIBLY CONTRIBUTE TO THE ISSUE. ROOT CAUSE WAS NOT IDENTIFIED. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.