WATERPIK WATER FLOSSER
Received Jun 20, 2018 · Event occurred May 25, 2018
Report 0001712259-2018-00003 · MDR key 7620618
Device
Product problems
- Detachment Of Device Component
- Crack
- Leak/Splash
Patient
40 YR
- Tinnitus
- Injury
- Tinnitus
- Injury
Narrative
Additional Manufacturer Narrative
UNIT IN QUESTION HAS NOT BEEN RETURNED FOR TESTING AND EVALUATION.
Description of Event or Problem
PER THE CUSTOMER....CLAIMS DEVICE FAILED DURING USE, FRONT FACEPLATE POPPED OFF AND HANDLE IS CRACKED OPEN EXPOSING PRESSURE SETTING AND CHARGE INDICATOR DIODES. CUSTOMER DENIES ANY USE OF ADDITIVES OR POTENTIAL FOR CHEMICAL ATTACK OR ANY OTHER MISUSE. CUSTOMER IDENTIFIED THIS CAUSED A MARK ON HIS HAND AND EARS TO RING BUT NOTHING MORE SEVERE. HE IS NOT SEEKING RESTITUTION FOR ANY INJURY. CUSTOMER CLAIMS UNIT LEAKED AFTER USE FROM DAY ONE AND DESCRIBES THE PUMP AS INCONSISTENT. UNIT HAS BEEN USED SINCE (B)(6) 2017.