MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for WATER PIK WP 660C manufactured by Water Pik Inc..
[65513194]
I attempted to clean this device and filthy water came out. The device had been in regular use. I use municipal water. Small clumps of dark algae appear to be in the output, dark black grains and mixed debris. Small ants may have gotten into the device, but no ants appear in the output. If so, the device should not permit ants to enter it. The pumping mechanism must be horribly moldy. I had been using this and with the tooth cleaning nozzles in place none of this debris came out or was observable. Some must have come out unnoticed. Frightening to me. I have just notified water pik. I see this product as a danger to the health of users. Product category: personal care. Product type: grooming. Purchase date: (b)(6) 2014. This date is an estimate. The product was damaged before the incident: no. The product was modified before the incident: no. Document number:(b)(6). Report number: (b)(6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067335 |
| MDR Report Key | 6266343 |
| Date Received | 2017-01-18 |
| Date of Report | 2017-01-02 |
| Date of Event | 2016-12-28 |
| Date Added to Maude | 2017-01-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WATER PIK |
| Generic Name | WATER PIK WHICH IS A WATER TOOTH FLOSSER |
| Product Code | EFS |
| Date Received | 2017-01-18 |
| Model Number | WP 660C |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-18 |