MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-22 for WATER PIK WP-100/450 manufactured by Water Pik.
[2376552]
Consumer stated that the water flosser continuously trips the breaker which means that the product is faulty and could cause electrocution. This product is used with electricity and water. On (b)(6) 2011 consumer stated that he contacted the manufacturer and was advised that there were aware of the problem and had a solution, and he was also advised to use a surge suppressor. Consumer feels that there is leakage of electricity in this product which is very unsafe and should be investigated. Retailer: (b)(4). . Purchase date: (b)(6) 2011 (this date is an estimate). The product was not damaged before the incident. The product was not modified before the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023296 |
| MDR Report Key | 2359418 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-28 |
| Date Added to Maude | 2011-12-08 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER PIK |
| Generic Name | WATER FLOSSER |
| Product Code | EFS |
| Date Received | 2011-11-22 |
| Model Number | WP-100/450 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK |
| Manufacturer Address | E. PROSPECT RD FT COLLINS CO 85503 US 85503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-22 |