MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-14 for WATERPIK WATER FLOSSER WP-130 manufactured by Water Pik, Inc..
[5637060]
Per the customer.... Using unit for a month or so 1x per week, a crown/fake tooth fell out. Continued use, thought dentist did a bad job. Front tooth crown/fake tooth fell out. Dentist is saying the water flosser caused them to come out. Was using 2 tips and will mark with tape the 2 in use. She wants water pik to pay for her new teeth and will send all docs.
Patient Sequence No: 1, Text Type: D, B5
[13191327]
Testing of returned unit showed pressures in normal range. Product operated normally. Bond strength of dental cements greatly exceed forces generated by the irrigator. Normal activities such as chewing food far exceed forces generated during irrigator use. All cements have a limited life and fail in time. The activity underway at the time of the cement failure is not the cause of the failure, it is only coincidental simultaneous activity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001712259-2015-00001 |
| MDR Report Key | 4688716 |
| Report Source | 04 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-04-13 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2015-02-24 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2015-04-14 |
| 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 | 0 |
| Event Location | 0 |
| 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 80553000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80553 0001 |
| 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 | 2015-04-14 |
| Returned To Mfg | 2015-03-16 |
| Model Number | WP-130 |
| Lot Number | 140414BJ |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 80553000 US 80553 0001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-14 |