MASK SURGICAL SENSITIVE WHITE

Additional Manufacturer Narrative

BASED IN THE INFORMATION PROVIDED FOR THIS PARTICULAR CODE WITH LOT NUMBER 19EGH567 THIS PRODUCT WAS MANUFACTURED ON MAY 23RD, 24TH, 25TH AND 27TH 2019 DURING FIRST AND SECOND SHIFTS. PER THE DEVICE HISTORY RECORD, NO QUALITY ISSUES WERE REPORTED. WE CONFIRMED THE FOLLOWING: WE REVIEWED OUR BATCH HISTORY RECORD AND NO QUALITY ISSUES OF THIS NATURE WERE REPORTED. ALL OPERATORS ARE CERTIFIED IN THEIR RESPECTIVE OPERATIONS. THE FAILURE MODE AND EFFECT ANALYSIS (FMEA) APPLICABLE TO THIS PRODUCT WAS REVIEWED. WE VERIFIED THAT THESE DEVICES ARE MADE WITH QUALIFIED, TESTED, AND APPROVED MATERIALS. BASED ON THE CODE PROVIDED. THE OPERATORS AND THE QUALITY INSPECTOR DID NOT IDENTIFY THIS CONDITION DURING THEIR PROCESS AND CONTINUOUS INSPECTION. INCLUDING DESTRUCTIVE TEST AND VISUAL INSPECTION FOR FIBERS AND SEAL CONDITIONS. PRODUCT WAS MADE TO MEET WITH THEIR SPECIFICATION REQUIREMENTS. A SAMPLE WAS NOT PROVIDED AT THIS TIME. AT THIS TIME A ROOT CAUSE COULD NOT BE IDENTIFIED. AS A PREVENTIVE ACTION WE WILL MAINTAIN THE FOLLOWING: AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE EMPLOYEES INVOLVED IN THE PROCESS OF THIS PRODUCT IN ORDER TO BE ALERT ABOUT THIS KIND OF ISSUES. OUR PRODUCT IS BEING MAINTAINED MONITORED BY THE QUALITY INSPECTOR DURING THEIR CONTINUOUS INSPECTION IN ORDER TO PREVENT THIS KIND OF ISSUES. SEALS AND (B)(4) MATERIAL ARE BEEN MONITORED ENSURING THEY DO NOT PRESENT CONDITIONS THAT MAY AFFECT THE FINAL USER.

Description of Event or Problem

BASED ON INFORMATION RECEIVED BY THE END-USER, EMPLOYEE (B)(6) REPORTEDLY WAS SEEN AT TWO DIFFERENT URGENT CARE CENTERS WITH ALLEGED SYMPTOMS OF A BURNING FEELING AROUND HER MOUTH, FACE AND NECK. SHE ALSO ALLEGES BREAKING OUT 2 TO 10 HOURS LATER THAT PROGRESSIVELY GOT WORSE. SHE WAS PRESCRIBED DECADRON AND HYDROCORTISONE 0.2% OINTMENT ON HER FIRST VISIT URGENT CARE VISIT. ON HER SECOND VISIT TO URGENT CASE SHE WAS PRESCRIBED PREDNISONE 5-DAY PACK AND TO CONTINUE USE OF TOPICAL CREAM AND BENADRYL.