MASK PROCEDURE

Additional Manufacturer Narrative

THE ACTUAL EVENT SAMPLE WAS PROVIDED FOR INVESTIGATION. BASED ON THE LOT NUMBER REPORTED, 20CMH195, THIS PRODUCT WAS MANUFACTURED ON MARCH 14TH 2020. THE REVIEW OF OUR BATCH HISTORY RECORD FOR THIS LOT NUMBER REVEALED NO QUALITY ISSUES OF THIS NATURE WERE REPORTED. ALL OPERATORS ARE CERTIFIED IN THEIR RESPECTIVE OPERATIONS. THE FAILURE MODE AND EFFECT ANALYSIS (FMEA) APPLICABLE FOR THIS PRODUCT WAS REVIEWED. WE VERIFIED THAT THESE DEVICES ARE MADE WITH QUALIFIED, TESTED, AND APPROVED MATERIALS BASED ON THE CODE PROVIDED. BASED ON OUR MANUFACTURING PROCESSES OF THIS PRODUCT, WE CAN DETERMINE THAT THE DEFECT REPORTED OCCURRED POSSIBLY IN SOME OF THE FOLLOWING PROCESSES, ASSEMBLY, SEALING OR DUE TO THE MATERIAL USED. AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE EMPLOYEES INVOLVED IN THE PROCESS OF THIS PRODUCT IN ORDER TO BE ALERT ABOUT THIS KIND OF ISSUE. OUR PRODUCT IS BEING MAINTAINED MONITORED BY THE QUALITY INSPECTOR DURING THEIR CONTINUOUS INSPECTION IN ORDER TO PREVENT THIS KIND OF ISSUE. SEALS AND RAW MATERIAL ARE BEING MONITORED ENSURING THEY DO NOT PRESENT CONDITIONS THAT MAY AFFECT THE END USER. WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

Description of Event or Problem

EMPLOYEE IN IMAGING SERVICES REPORTED DEVELOPING SKIN IRRITATION/RASH AFTER WEARING MASK. EMPLOYEE HAS A LATEX ALLERGY. SHE WENT TO THE EMERGENCY DEPARTMENT WITH EYE SWELLING AND WAS GIVEN ORAL PREDNISONE. EMPLOYEE FINISHED PREDNISONE DOSE PACK AND REPORTS SHE IS DOING FINE NOW.