PFR95 PART FILT RESP

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 21CFR803, 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

A MEDWATCH REPORT (MW5145095) WAS RECEIVED THROUGH FDA¿S MEDWATCH PROGRAM ON (B)(6) 2023. THE CUSTOMER CONTRACTED COVID-19 AND WAS FULLY VACCINATED. CUSTOMER INDICATED THEY WERE EXTREMELY CAREFUL WEARING A CLEAN HALYARD N95 DUCKBILL MASK. ALMOST A YEAR LATER THE CUSTOMER STILL SUFFERS WITH LONG-TERM COVID SYMPTOMS AND SIDE EFFECTS THAT ARE IMPACTING THEIR HEALTH AND WELLNESS. THE INITIAL BINAXNOW COVID-19 TEST WAS CONFIRMED WITH IHEALTH AND SENT TO THE CDC. CUSTOMER SUBSEQUENTLY INDICATED THEY SUSPECTED THEY CAUGHT COVID ON A PLANE FROM LONDON TO SFO. CUSTOMER WAS MASKED ON THE PLANE FLIGHT OTHER THAN WHEN QUICKLY EATING. THERE WAS NO MEDICAL INTERVENTION OTHER THAN OVER THE COUNTER MEDICATION. THE CUSTOMER INDICATED THEY HAVE RESIDUAL FATIGUE, MUSCLE ACHES, TINGLING FEET AND ELBOW, OVERACTIVE BLADDER, AND INCREASE IN HEMOGLOBIN. CUSTOMER FOLLOWS UP WITH PHYSICIAN REGULARLY BUT NEVER HAD ANY OF THESE ISSUES PRIOR TO CONTRACTING VIRUS.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR PRODUCT CODE: 46727 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURE AND SPECIFICATIONS, THEN RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT PRODUCTION. THE MATERIALS CORRESPONDING TO PRODUCT: 46727 WERE ANALYZED AND ACCORDING TO THE INCOMING INSPECTION THE RAW MATERIAL WAS IN CONFORMANCE WITH SPECIFICATION. A 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, 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.