MASK PROCEDURE YELLOW

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO QUALITY ISSUES WERE REPORTED. A REVIEW OF THIS PRODUCT CATALOG NUMBER IDENTIFIED NO TRENDS FOR THIS ISSUE IN THE LAST TWELVE MONTHS. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION AS IT HAD BEEN DISCARDED AFTER USE. THE REPORTED LOT NUMBER DID NOT MATCH THE MANUFACTURING RECORDS, HOWEVER THE MANUFACTURING FACILITY WAS ABLE TO IDENTIFY THE SUSPECTED LOT NUMBER. IT WAS VERIFIED THAT THESE DEVICES ARE MADE WITH QUALIFIED, TESTED, AND APPROVED MATERIALS; AND THAT THE PRODUCT WAS MADE TO MEET SPECIFICATION REQUIREMENTS. THE MASK IS NOT MADE WITH NATURAL RUBBER LATEX, AND THIS MATERIAL IS NOT USED IN OUR MANUFACTURING PROCESSES. THE POTENTIAL ROOT CAUSE COULD NOT BE IDENTIFIED. ALL OPERATORS ARE CERTIFIED IN THEIR RESPECTIVE OPERATIONS. AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE INVOLVED EMPLOYEES TO ALERT THEM OF THIS ISSUE; AND THE PRODUCT IS MONITORED BY A QUALITY INSPECTOR. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY SUCH ISSUES.

Description of Event or Problem

NURSE WORE MASK MAJORITY OF SHIFT. NOTICED NOSE/NECK/LOWER JAWLINE WAS RED AND IRRITATED - IRRITATED AREAS PROCEEDED TO A RED RASH. SAW FAMILY PHYSICIAN WHO THOUGHT IT WAS CONTACT DERMATITIS FROM THE MASK AND PRESCRIBED PREDNISONE AND ZANTAC. SYMPTOMS PERSISTED EXTENDING TO LOWER NECK, THROAT (IRRITATED, GLANDS SWOLLEN), AND HANDS HAVING RASH ON KNUCKLES. SHE THEN SAW THE EMPLOYEE HEALTH PHYSICIAN WHO BELIEVED IT WAS AN ALLERGY TO LATEX. SHE IS TAKING A TAPERING PACK OF METHYLPREDNISONE AND HYDROCORTISONE CREAM, AND IS TO SEE AN ALLERGIST. THE NURSE IS NOT CERTAIN IF THE MASK CAUSED HER SYMPTOMS. CARDINAL HEALTH IS PROACTIVELY FILING THIS.