MAUDE MDR 2434529

MDR report key
2434529
Report number
MW5024047
Event key
0
Event type
3
Date of event
2011-10-08
Date received
2012-01-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
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
1WATERPIK SINUSENSESINUS IRRIGATORWATER PIK, INCKMASINUSENSE SWI 615

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-01-2401. R

Event Narratives#

D

Patient 1

I PURCHASED A WATERPIK SINUSENSE AUTOMATIC (ELECTRIC/BATTERY POWERED) SINUS CLEANER FROM (B)(6) ABOUT A MONTH AGO. I HAVE SERIOUS SINUS ISSUES AND FOR THE FIRST WEEK, THE SINUSENSE WAS HELPING GREATLY. THEN, MY SINUS PROBLEMS STARTED GETTING WORSE THAN THEY WERE BEFORE I STARTED USING THE PRODUCT. COME TO FIND OUT, THE BATTERY COMPARTMENT WAS LEAKING BATTERY ACID INTO THE STERILE SALINE COMPARTMENT. BASICALLY, I WAS FLUSHING MY SINUSES WITH EXTREMELY HARMFUL BATTERY ACID. I AM NOW WORRIED THAT I DID PERMANENT DAMAGE TO MY SINUSES. I FOLLOWED EVERY DIRECTION TO THE T, AND I IN NO WAY MISUSED THIS PRODUCT. I DID A SEARCH FOR THE PRODUCT ONLINE AND ALMOST EVERYONE IS HAVING THE SAME PROBLEM WITH THIS DEVICE. WATERPIK DOESN'T SEEM TO THINK IT'S A BIG DEAL, AND ONLY OFFERS TO REPLACE THE PRODUCT WHEN PEOPLE COMPLAIN. THIS IS SERIOUS. MANY UNSUSPECTING PEOPLE WITH THIS PRODUCT COULD BE FLUSHING THEIR SINUSES WITH BATTERY ACID AS WE SPEAK. YOU CAN READ SOME OF THE REVIEWS FOR THE PRODUCT HERE: (B)(4). RETAILER: (B)(6). THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT.