WATERPIK WATER FLOSSER
Received Jun 8, 2015 · Event occurred May 18, 2015
Report 0001712259-2015-00003 · MDR key 4825156
Device
Product problems
- Split
Patient
40 YR
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
INSPECTION OF RETURNED UNIT SHOWED THAT THE IRRIGATOR HOSE WAS BROKEN BELOW THE HANDLE. THE HOSE MATERIAL WAS BRITTLE AND COULD EASILY BE BROKEN IN THE AREA BELOW THE HANDLE AND INVOLVING THE FIRST COIL OF THE HOSE. THE REMAINDER OF THE HOSE COILS WERE FLEXIBLE AND NORMAL. IT APPEARS THAT THE HOSE MATERIAL WAS ATTACHED AND DEGRADED BY A CHEMICAL. THIS MAY HAVE BEEN A MEDICAMENT THAT RAN DOWN THE HANDLE/HOSE DURING USE OR IT MAY HAVE BEEN DUE TO OVER SPRAY FROM A MATERIAL SUCH AS HAIR SPRAY.
Description of Event or Problem
PER THE CUSTOMER...."USED THE WP-100PLT FRIDAY (B)(6) 2015 IN THE FRONT NEAR THE BRIDGE ON TOP OF THE MOUTH. THE HOSE SPLIT DURING USE, SCARED HER. TOOK THE TIP OUT OF MOUTH AND PART OF BRIDGE OR CROWN CAME OUT. MUST HAVE HAPPENED WHEN THE HOSE BROKE AND MAYBE BANGED IT INTO HER TOOTH AND BROKE THE BRIDGE OR CROWN."
Description of Event or Problem
PER THE CUSTOMER...."USED THE WP-100PLT FRIDAY (B)(6) 2015 IN THE FRONT NEAR THE BRIDGE ON TOP OF THE MOUTH. THE HOSE SPLIT DURING USE, SCARED HER. TOOK THE TIP OUT OF MOUTH AND PART OF BRIDGE OR CROWN CAME OUT. MUST HAVE HAPPENED WHEN THE HOSE BROKE AND MAYBE BANGED IT INTO HER TOOTH AND BROKE THE BRIDGE OR CROWN."
Additional Manufacturer Narrative
UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION. DEVICE IN QUESTION HAS NOT BEEN RECEIVED.