FDA.reportPublic FDA data

MAUDE MDR 6278908

MDR report key
6278908
Report number
MW5067449
Event key
0
Event type
3
Date of event
2013-01-11
Date received
2017-01-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1NETI POTAPPPLICATOR, ENTNEILMED PHARMACEUTICALS, INC.KCJ* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-2401. O

Event Narratives#

D

Patient 1

AFTER USING THE NETI POT FOR SINUS CONGESTION I DEVELOPED A VERY SORE THROAT THAT WOULDN'T GO AWAY. I FINALLY HAD A THROAT CULTURE DONE AND IT SHOWED I HAD AN OVERGROWTH OF YEAST. IT WAS FROM THE CONSTANT IRRIGATION OF MY NOSE/THROAT AND IT RINSED ALL THE "GOOD BACTERIA" AWAY AND PRE-DISPOSED ME TO DEVELOPING A THROAT YEAST INFECTION. DATE OF USE: (B)(6) 2013 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: CHRONIC NASAL CONGESTION, SINUSITIS. IS THE PRODUCT OVER-THE-COUNTER: YES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.