WATERPIK WATER FLOSSER
Received Apr 14, 2015 · Event occurred Feb 24, 2015
Report 0001712259-2015-00001 · MDR key 4688716
Device
Product problems
- Break
Patient
40 YR
- Failure of Implant
Narrative
Additional Manufacturer Narrative
TESTING OF RETURNED UNIT SHOWED PRESSURES IN NORMAL RANGE. PRODUCT OPERATED NORMALLY. BOND STRENGTH OF DENTAL CEMENTS GREATLY EXCEED FORCES GENERATED BY THE IRRIGATOR. NORMAL ACTIVITIES SUCH AS CHEWING FOOD FAR EXCEED FORCES GENERATED DURING IRRIGATOR USE. ALL CEMENTS HAVE A LIMITED LIFE AND FAIL IN TIME. THE ACTIVITY UNDERWAY AT THE TIME OF THE CEMENT FAILURE IS NOT THE CAUSE OF THE FAILURE, IT IS ONLY COINCIDENTAL SIMULTANEOUS ACTIVITY.
Description of Event or Problem
PER THE CUSTOMER....USING UNIT FOR A MONTH OR SO 1X PER WEEK, A CROWN/FAKE TOOTH FELL OUT. CONTINUED USE, THOUGHT DENTIST DID A BAD JOB. FRONT TOOTH CROWN/FAKE TOOTH FELL OUT. DENTIST IS SAYING THE WATER FLOSSER CAUSED THEM TO COME OUT. WAS USING 2 TIPS AND WILL MARK WITH TAPE THE 2 IN USE. SHE WANTS WATER PIK TO PAY FOR HER NEW TEETH AND WILL SEND ALL DOCS.