N
Patient 1
UNIT IN QUESTION HAS NOT YET BEEN RETURNED FOR TESTING AND EVALUATION.
MAUDE MDR 6106048
- MDR report key
- 6106048
- Report number
- 0001712259-2016-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-10-28
- Date received
- 2016-11-16
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WATERPIK WATER FLOSSER | ORAL IRRIGATOR | WATER PIK, INC. | EFS | WP-140 | N | N | |||||
| 714919 | WATERPIK WATER FLOSSER | ORAL IRRIGATOR | WATER PIK, INC. | EFS | WP-140 | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-16 | 0 | 1. O |
Event Narratives#
D
Patient 1
PER THE CUSTOMER....CLAIMS USE OF PRODUCT CAUSED ONE OF HER BOTTOM FRONT TEETH TO CHIP. CUSTOMER WAS USING AT PRESSURE SETTING 6 AND ATTEMPTING TO REMOVE DEBRIS WHEN SHE CLAIMS THE STREAM OF WATER HAD CREATED A CONCAVE INDENTATION IN THE TOOTH. CUSTOMER CLAIMS HER DENTIST IDENTIFIED THE FLOSSER AS CAUSING AN OTHERWISE HEALTHY TOOTH TO CHIP.