FDA.reportPublic FDA data

MAUDE MDR 9853384

MDR report key
9853384
Report number
MW5093843
Event key
0
Event type
3
Date of event
2020-03-15
Date received
2020-03-18
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
1DISPOSABLE PARTICLE RESPIRATOR FACE MASK COATED IN TEA TREE OR ALOE VERA ESSENTIMASK, OXYGENUNKNOWNBYGI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives#

D

Patient 1

(B)(6) ONLINE SELLING DISPOSABLE PARTICLE RESPIRATOR FACE MASK COATED IN TEA TREE OR ALOE VERA ESSENTIAL OIL. THIS PRODUCT DID NOT GET REGISTERED WITH FDA, THE COMPANY WAS NOT REGISTERED FOR SELLING THIS KIND OF MEDICAL PRODUCT. THE PRODUCTS ACTUALLY ARE REGULAR FACE MASKS FROM (B)(6), TO SELL THEM AT HIGH PRICES DURING OUTBREAK OF COVID-19, THE COMPANY CLAIMS COATED WITH TEA TREE OR ALOE VERA ESSENTIAL OIL. THIS IS MISLEADING. (B)(6) WAS WARNED BY FDA AND FTC PREVIOUSLY. THIS COMPANY KEEPS DOING THE SAME BAD THINGS. (B)(6) INC. FDA SAFETY REPORT ID# (B)(4).