Description of Event or Problem · 1
MY THREE CHILDREN HAVE ADVERSE EFFECTS TO THE FACE MASKS AUTHORIZED UNDER EMERGENCY USE AUTHORIZATION BY THE FDA FOR USE AS SOURCE CONTROL DURING THE COVID-19 PANDEMIC IN ACCORDANCE TO FD&C SECTION 564 & ACT (21 U.S.C. 360 BBB-3). MY CHILDREN HAVE DEMONSTRATED TO BE INTOLERANT OF LONG-TERM FACE MASK WEARING. MY (B)(6) SON AND MY (B)(6) DAUGHTER HAVE BOTH HAD RASHES, THAT ARE SIMILAR TO FUNGAL INFECTION BLISTERS UNDER THEIR NOSE (MY SON) ON HIS LEFT CHEEK AS WELL. AFTER ONLY 20 MINUTES OF MASKING MY (B)(6) SON COMPLAINS OF DIZZINESS AND A SHARP STOMACH PAIN ON HIS LEFT SIDE. MY DAUGHTER COMPLAINS OF ITCHINESS AND FEELING DIZZY. I HAVE AN APPOINTMENT SCHEDULED FOR THEM IN AUGUST TO REPORT THESE SYMPTOMS TO THEIR PEDIATRICIAN. MY (B)(6) STEPSON DOES NOT GET RASHES FROM MASKING, HOWEVER, HE HAS SHOWN TO BE INTOLERANT OF MASKING BY FEELING DIZZINESS, EXHAUSTION AND THE SHARP STOMACH PAIN ON HIS LEFT SIDE (THAT MY (B)(6) COMPLAINTS OF). ALL THIS AFTER HALF AN HOUR OF MASKING AND DIFFICULTY BREATHING AFTER 20 MINUTES OF MASKING. THESE SYMPTOMS MY STEP-SON HAS EXPERIENCED FROM MASKING HAVE BEEN REPORTED TO HIS PEDIATRICIAN ON (B)(6) 2021. WE LIVE IN (B)(6) AND THE SCHOOLS THAT MY CHILDREN WILL BE ATTENDING HAVE NOTIFIED PARENTS THAT THEY WILL BE FOLLOWING THE CDC'S GUIDELINES OF IN-DOOR MANDATORY FACE MASK. MY CHILDREN WILL NOT TOLERATE SIX HOURS A DAY FIVE DAYS A WEEK OF MASKING. THEY GET DIZZY, PAIN AND RASHES FROM ONLY MASKING UNDER AN HOUR OF MASK USE. I HAVE A VARIETY OF FACE MASKS (CLOTH, SILK AND MEDICAL) THAT THEY HAVE ALL TRIED, AND I WILL ATTACH A PICTURE OF THEM. THEY DO NOT TOLERATE ANY OF THE MASKS I HAVE BOUGHT THEM. MY STEP-SONS PEDIATRICIAN HAS WRITTEN A NOTE FOR HIS SCHOOL, HOWEVER STATED THERE IS A CLEAR CONFLICT OF INTEREST SINCE ALL (B)(6) SCHOOLS AND SCHOOL DISTRICTS ARE EXPECTED TO COMPLY TO THE (B)(6) DEPARTMENT OF PUBLIC HEALTH MASK MANDATES AND COVID-19 GUIDELINES. THE ONLY CDPH MASK EXCEPTION IS IF CHILDREN HAVE DISABILITIES, MEDICAL CONDITIONS AND COGNITIVE IMPAIRMENT. MY CHILDREN DON'T MEET THOSE EXEMPTION GUIDELINES, BUT THEY HAVE PROVEN TO HAVE INTOLERANCE TO FACE MASKS WITH THE SYMPTOMS MENTIONED. I AM NOT WILLING TO PUT MY CHILDREN IN HARMS WAY, THIS IS A DEVICE AUTHORIZED BY EUA. IT IS WELL KNOWN THAT STATISTICALLY CHILDREN HAVE A SURVIVAL RATE OF 99.997% FROM THE COVID-19 VIRUS, IT DOES NOT JUSTIFY A MASK MANDATE. THIS IS A CRUEL THING TO MANDATE ON CHILDREN. OTHER PARENTS ARE ALSO AWARE IN (B)(6) THAT THIS MASK MANDATE IN SCHOOLS IS NOT IN THE BEST INTEREST OF THE CHILDREN, ESPECIALLY IF THEY ARE HAVING ADVERSE REACTIONS TO THE MASKS LIKE MY CHILDREN ARE. PLEASE ADVISE THE (B)(6) DEPARTMENT OF PUBLIC HEALTH OFFICIALS THAT MANDATING FACE COVERINGS ON CHILDREN FOR FIVE DAYS A WEEK SIX HOURS A DAY IN-DOORS AT SCHOOLS IS A ONE-SIZE FITS ALL APPROACH AND THERE IS NOT ENOUGH EVIDENCE TO KNOW THE LONG-TERM HEALTH EFFECTS THIS COULD HAVE ON CHILDREN. THANK YOU. "DEVICE" UNDER SECTION 201(H) OF THE ACT. CFR 878.4040 AS CLASS 1 510(K). FDA SAFETY REPORT ID # (B)(4).