FDA.reportPublic FDA data

MAUDE MDR 7352173

MDR report key
7352173
Report number
MW5075954
Event key
0
Event type
3
Date of event
2018-03-12
Date received
2018-03-19
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOCLEANDISINFECTANT, MEDICAL DEVICESSOCLEAN INC.LRJSC1200I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-190

Event Narratives#

D

Patient 1

AFTER APPROXIMATELY 3 MONTHS OF USING SOCLEAN 2 CPAP CLEANER I NOTICED I WAS GETTING SICK, STARTED HAVING CHEST PAINS FOR SHORT PERIODS OF TIME EACH DAY AND FELT TIRED ALL THE TIME. AFTER RESEARCH OF THE PRODUCT, FOUND IT USES OZONE TO DISINFECT AND FOUND I HAD MOST OF THE SYMPTOMS OF EXCESS OZONE IN MY SYSTEM. AFTER 3 DAYS OF NOT USING IT I AM FEELING MUCH BETTER WITH NO INSTANCES OF CHEST PAIN AND MY COLD IS GOING AWAY ALONG WITH MY LUNGS CLEARING UP. I WILL BE SEEING MY DOCTOR IN 2 WEEKS TO BE REFERRED TO A CARDIOLOGIST FOR ASSESSMENT.