FDA.reportPublic FDA data

MAUDE MDR 344191

MDR report key
344191
Report number
MW1022501
Event key
0
Event type
3
Date of event
2001-07-30
Date received
2001-07-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHARPER IMAGEAIR PURIFIER/IONIZERSHARPER IMAGEFRFUNKUNKNANN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-07-310

Event Narratives#

D

Patient 1

PURIFIER USES THE PRINCIPLE OF IONIZATION AND IT CREATES OZONE. 100 PPBILLION OF OZONE WAS MEASURED AND RPTR THINKS THIS IS TOO MUCH. CONCERNS RELATED TO STORE MGR. RPTR BELIEVES DEVICE IS UNSAFE.