MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for WATERPIK WATER FLOSSER WP-660 manufactured by Water Pik, Inc..
[66763980]
Unit in question has not been returned for testing and evaluation. Device in question has not been received.
Patient Sequence No: 1, Text Type: N, H10
[66763981]
Per the customer, this unit works fine but as i tried to clean it large, amounts of filthy water came out. I saved a sample, it contained clumps of what seemed to be dark algae, black grains, particles of all sorts. I use good municipal water (seacoast water in (b)(6)). I often use an ounce of (b)(6) when flossing with a batch of water. I use warm water mostly. Here in (b)(6) small ants are a problem. Could they have gotten into the internals? I see no ant bodies in the output. The debris that came out when i ran it with the nozzle out was scary and now even trying to clean with peroxide will not give me confidence that i will not have lots of strange material in my waterpik. What can i do? I suspect what is happening to mine is a serious health hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2017-00001 |
| MDR Report Key | 6300438 |
| Date Received | 2017-02-03 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-01-02 |
| Date Mfgr Received | 2017-01-02 |
| Device Manufacturer Date | 2013-11-19 |
| Date Added to Maude | 2017-02-03 |
| 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 | 0 |
| Brand Name | WATERPIK WATER FLOSSER |
| Generic Name | ORAL IRRIGATOR |
| Product Code | EFS |
| Date Received | 2017-02-03 |
| Model Number | WP-660 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-02-03 |