HALYARD FLUIDSHIELD N95 RESPIRATOR
Received Apr 18, 2023 · Event occurred Apr 12, 2023
Report MW5116813 · MDR key 16770764
Device
Product problems
- Nonstandard Device
Patient
38 YR · Female
- Viral Infection
- Viral Infection
Narrative
Description of Event or Problem
I AM A PRIMARY CARE PHYSICIAN. OVER THE PAST 3+ YEARS, I HAVE CARED FOR PATIENTS, INCLUDING THOSE WHO HAVE COVID-19, IN MY OFFICE. I WENT 3+ YEARS WITHOUT GETTING COVID-19, OR ANY OTHER SYMPTOMATIC BACTERIAL/VIRAL ILLNESS (I TEST MYSELF FOR COVID REGULARLY, AS I AM FREQUENTLY IN CONTACT WITH MY ELDERLY/IMMUNOCOMPROMISED PARENTS). AN IMPORTANT PART OF MY STRICT INFECTION CONTROL PROTOCOL HAS BEEN TO WEAR MY HALYARD FLUIDSHIELD N95 RESPIRATOR (MODEL 46727) WHENEVER I AM IN THE OFFICE. 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 HAD RECEIVED IN JAN 2023. ON (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. "OH WELL," I THOUGHT, "I GUESS MY GOOD LUCK WITH OBSESSIVELY AVOIDING COVID-19 AT WORK FINALLY RAN OUT." IMAGINE MY SHOCK WHEN I SAW TODAY THAT MY TRUSTY RESPIRATOR HAD BEEN RECALLED. I AM BEYOND FRUSTRATED THAT THIS PRODUCT FAILURE PUT ME (AND MY FAMILY, AND MY PATIENTS) AT RISK.