PFR95 PART FILT RESP

Description of Event or Problem

A REPORT WAS RECEIVED FROM (B)(6) STATING THE DOCTOR HAD A REACTION TO THE FACE MASKS. THE DOCTOR EXPERIENCED SORE THROAT, RUNNY NOSE, NASAL BLOCKAGE, LARYNGITIS AND SKIN REACTION AROUND THE MOUTH AND NOSE. THE DOCTOR DIAGNOSED AND SELF TREATED HERSELF WITH ANTI-HISTAMINES AND A CORTISONE BASED TOPICAL OINTMENT. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE DOCTOR'S STATUS.

Additional Manufacturer Narrative

(B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ROOT CAUSE COULD NOT BE DETERMINED. SIX UNUSED MASKS WERE RETURNED BUT A LOT NUMBER AND THE ORIGINAL PACKAGING WERE NOT PROVIDED. ALL SIX DEVICES WERE INTACT AND HAD NO ROUGH SURFACES, EXCESS MATERIAL OR OTHER VISUAL DEFECTS. (B)(4) HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH 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 HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.