MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-02 for WATERPLK WPI00W manufactured by Waterpik.
[25283220]
I purchased a new waterpik appliance this year. I have had several in the past. I noticed this one was very light compared to the others. When in use, it slides across the counter and if not grabbed (while flossing) would land in the sink. It is plugged into the wall so i consider it a shock hazard. I contacted waterpik and they told me to put a rag under the appliance. Can you imagine that? Something should be done to make it more stable. I had to put a cork hot plate under it to keep it still. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056018 |
| MDR Report Key | 5061625 |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-23 |
| Date of Event | 2015-08-21 |
| Date Added to Maude | 2015-09-08 |
| 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 | WATERPLK |
| Generic Name | WATERPIK MODEL WP100W |
| Product Code | EFS |
| Date Received | 2015-09-02 |
| Model Number | WPI00W |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERPIK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |