FDA.reportPublic FDA data

MAUDE MDR 2532190

MDR report key
2532190
Report number
MW5024967
Event key
0
Event type
3
Date of event
2012-03-24
Date received
2012-04-09
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
1WATER PIKNONEKARSWI615

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-090

Event Narratives#

D

Patient 1

MY DAUGHTER AND I PURCHASED A WATER PIK SINUSENSE BATTERY OPERATED NASAL WASH TO HELP US WITH A SEVERE COLD THAT WE'VE BEEN DEALING WITH. ON ABOUT THE THIRD DAY, I NOTICED A BROWNISH LIQUID DRIPPING OUT OF THE BATTERY COMPARTMENT AND INTO THE SALINE TO BE RINSED THROUGH OUR SINUSES. I OPENED THE BATTERY COMPARTMENT TO FIND THE BATTERIES CORRODED. I THOUGHT FOR SURE I MUST HAVE DONE SOMETHING WRONG, SO I CLEANED THE ENTIRE MACHINE AND INSTALLED FRESH BATTERIES. THE SECOND SET OF BATTERIES CORRODED WITHIN 24 HOURS. NOW I'M LEFT WONDERING WHICH OF MY/OUR SYMPTOMS ARE AS A RESULT OF THE CHEMICALS FROM THE BATTERIES BEING INHALED/INGESTED, AND HOW MANY ARE JUST NORMAL COLD. IT ONLY TOOK A BRIEF SEARCH ONLINE TO FIND MANY OTHERS WITH THE SAME COMPLAINT. SALINE LEAKING INTO THE BATTERY COMPARTMENT AND CHEMICALS LEAKING BACK OUT. (B)(6). THIS DATE IS AN ESTIMATE. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT.