FDA.reportPublic FDA data

MAUDE MDR 7472673

MDR report key
7472673
Report number
MW5076894
Event key
0
Event type
3
Date of event
2018-03-12
Date received
2018-04-27
Adverse event
3
Product problem
3
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
1SOCLEAN2CPAP SANITIZERUNKLRJSC1200I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-2701. O; 2. S

Event Narratives#

D

Patient 1

PURCHASED A SOCLEAN 2 CPAP SANITIZER FROM APRIA DIRECT HEALTH CARE. UPON USING MACHINE A STRONG ODOR WAS NOTED ON MASK, BUT WAS TOLD THIS WAS NORMAL AND THAT IT WAS LIKE THE OCEAN SMELL. AFTER THE FIRST WEEK I BEGAN HAVING TROUBLE WITH MY BREATHING. IT CONTINUED TO GET WORSE. STARTED BREATHING TREATMENTS AND PREDNISONE DID NOT HELP. I THEN FOUND OUT THAT THEY USED OZONE TO SANITIZE THE CPAP MACHINE. CHECKED THE (B)(6) CLINIC WEB SITE ONLY TO FIND OZONE IS AN IRRITANT AND CAN CAUSE ASTHMA ATTACKS. CALLED APIRA DIRECT AND THEY TOLD ME TO RETURN THE MACHINE. THEY DO NOT ADVISE YOU OF THIS DANGER. I ENDED UP IN AN URGENT CARE CENTER TODAY FOR THE ASTHMA ATTACK.