InjuryEFS
WATERPIK WATER FLOSSER
Received Feb 10, 2016 · Event occurred Feb 5, 2016
Report 0001712259-2016-00002 · MDR key 5427387
Device
Product problems
- Device Operates Differently Than Expected
Patient
40 YR
- Abscess
- Bacterial Infection
- Abscess
- Bacterial Infection
Narrative
Additional Manufacturer Narrative
UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION. DEVICE IN QUESTION HAS NOT BEEN RECEIVED.
Description of Event or Problem
PER THE CUSTOMER....CLAIMS USE OF PRODUCT HAS CAUSED AN ABCESS IN HER GUM. CLAIMS INADEQUATE DRAINAGE OF THE WATER PATHWAY ALLOWED BACTERIA TO DEVELOP IN THE UNIT AND ALLEGES THIS BACTERIA WAS FORCED INTO HER GUMS. SHE DESCRIBES A VISIBLE BUILDUP AS OCCURRING IN THE HANDLE ASSEMBLY. SHE SAYS A TYPICAL USE CYCLE CONSISTS OF USING THE CLASSIC JET TIP AT PRESSURE SETTINGS VARYING FROM 3-5.