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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WATER PIK INC. WATER PIK; WATER PIK WHICH IS A WATER TOOTH FLOSSER
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WATER PIK INC. WATER PIK; WATER PIK WHICH IS A WATER TOOTH FLOSSER Back to Search Results
Model Number WP 660C
Medical Device Problem Codes Device Contamination With Biological Material (2908); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/28/2016
Type of Reportable Event Serious Injury
Event or Problem Description
I attempted to clean this device and filthy water came out.The device had been in regular use.I use municipal water.Small clumps of dark algae appear to be in the output, dark black grains and mixed debris.Small ants may have gotten into the device, but no ants appear in the output.If so, the device should not permit ants to enter it.The pumping mechanism must be horribly moldy.I had been using this and with the tooth cleaning nozzles in place none of this debris came out or was observable.Some must have come out unnoticed.Frightening to me.I have just notified water pik.I see this product as a danger to the health of users.Product category: personal care.Product type: grooming.Purchase date: (b)(6) 2014.This date is an estimate.The product was damaged before the incident: no.The product was modified before the incident: no.Document number:(b)(6).Report number: (b)(6.
 
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Brand Name
WATER PIK
Common Device Name
WATER PIK WHICH IS A WATER TOOTH FLOSSER
Manufacturer (Section D)
WATER PIK INC.
MDR Report Key6266343
Report NumberMW5067335
Device Sequence Number726777
Product Code EFS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 01/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model NumberWP 660C
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/18/2017
Patient Sequence Number1
Patient Age68 YR
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