WATERPIK WATER FLOSSER
Received Sep 24, 2015 · Event occurred Sep 23, 2015
Report 0001712259-2015-00006 · MDR key 5101391
Device
Product problems
- Increase in Pressure
Patient
11 YR
- Abrasion
Narrative
Additional Manufacturer Narrative
UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION.
Description of Event or Problem
PER THE CUSTOMER....FATHER CLAIMS THE (B)(6) DAUGHTER INJURED THE ROOF OF HER MOUTH WHILE FLOSSING. SAYS DAUGHTER HAS USED HER WP-360 FOR SOME TIME WITH THE HIGH PRESSURE TIP AND HAS HAD NO PROBLEMS. SUDDENLY THE PRESSURE BECAME MUCH HIGHER THAN USUAL AND CAUSED SMALL ABRASIONS ON THE ROOF OF HER MOUTH. DAUGHTER HAS BRACES, DID NOT RECEIVE MEDICAL ATTENTION AND ABRASIONS HEALED QUICKLY. CUSTOMER REQUESTED A REPLACEMENT UNIT.
Additional Manufacturer Narrative
RETURNED UNIT TESTED AND FOUND TO BE WITHIN THE NORMAL OPERATING PRESSURE RANGE AND WAS OPERATING AS DESIGNED. THERE IS NO KNOWN SITUATION WHERE PRESSURE CAN TEMPORARILY INCREASE. MOST LIKELY SITUATION IS THAT CUSTOMER AIMED WATER JET AT SOFT TISSUE INSTEAD OF GUM AREA AND CAUSED PAIN. THIS IS WARNED AGAINST IN THE PRODUCT INSTRUCTIONS FOR USE.
Description of Event or Problem
PER THE CUSTOMER....FATHER CLAIMS THE (B)(6) YEAR OLD DAUGHTER INJURED THE ROOF OF HER MOUTH WHILE FLOSSING. SAYS DAUGHTER HAS USED HER WP-360 FOR SOME TIME WITH THE HIGH PRESSURE TIP AND HAS HAD NO PROBLEMS. SUDDENLY THE PRESSURE BECAME MUCH HIGHER THAN USUAL AND CAUSED SMALL ABRASIONS ON THE ROOF OF HER MOUTH. DAUGHTER HAS BRACES, DID NOT RECEIVE MEDICAL ATTENTION AND ABRASIONS HEALED QUICKLY. CUSTOMER REQUESTED A REPLACEMENT UNIT.