FDA.reportPublic FDA data

MAUDE MDR 4643317

MDR report key
4643317
Report number
MW5041665
Event key
0
Event type
3
Date of event
2015-01-01
Date received
2015-03-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BREATHTEK SOLUTIONBREATHTEK SOLUTIONOTSUKA AMERICAMSQ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-2201. S

Event Narratives#

D

Patient 1

I RECENTLY LEARNED THAT YOU (FDA) HAVE APPROVED THE BREATHTEK SOLUTION FOR USE IN CHILDREN. THIS PRODUCT SHOULD HAVE BEEN REMOVED FROM THE MARKET ENTIRELY. NO CHILD OR ADULT SHOULD EXPERIENCE THE PAIN I SUFFER FROM AFTER CONSUMING THIS SOLUTION. I NOTIFIED THE CO AND REGISTERED A COMPLAINT TO THE FDA IN 2011. I SUFFER FROM BURNING HAND AND FEET SYNDROME AFTER CONSUMING THIS PRODUCT. I STILL SUFFER TODAY.