MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-19 for WATERPIK WATER FLOSSER WP-150 manufactured by Water Pik, Inc..
[97786915]
Unit in question has not been returned for testing and evaluation.
Patient Sequence No: 1, Text Type: N, H10
[97786916]
Per the customer.... Claims use of the wp-150 caused damage to a tooth. Customer admittedly has "had work done" in affected area in the past (customer approximated 8 years ago). Customer accepts the concept of wear and tear affecting the life of oral prosthetics, maintains that waterpik should compensate by mentioning to avoid high pressures in areas featuring dental work (not present in product literature). Customer is seeking restitution for repair and mentioned liability for time missed at work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2018-00001 |
| MDR Report Key | 7206706 |
| Report Source | CONSUMER |
| Date Received | 2018-01-19 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2017-09-29 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT VANDER VLIET |
| Manufacturer Street | 1730 EAST PROSPECT ROAD |
| Manufacturer City | FORT COLLINS CO 805530001 |
| Manufacturer Country | US |
| Manufacturer Postal | 805530001 |
| Manufacturer Phone | 9702217063 |
| Manufacturer G1 | WATER PIK, INC. |
| Manufacturer Street | 1730 EAST PROSPECT ROAD |
| Manufacturer City | FORT COLLINS CO 805530001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 805530001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERPIK WATER FLOSSER |
| Generic Name | ORAL IRRIGATOR |
| Product Code | EFS |
| Date Received | 2018-01-19 |
| Returned To Mfg | 2018-01-23 |
| Model Number | WP-150 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK, INC. |
| Manufacturer Address | 1730 EAST PROSPECT ROAD FORT COLLINS CO 805530001 US 805530001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-19 |