FDA Adverse Event
Malfunction
Summary report: N
WATER PIK
MDR report key: 2359418
·
Received November 22, 2011
Report
- Report Number
- MW5023296
- Event Type
- Malfunction
- Date Received
- November 22, 2011
- Date of Event
- September 28, 2011
- Report Date
- September 28, 2011
- Manufacturer
- WATER PIK
- Product Code
- EFS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WATER PIK | WATER FLOSSER | EFS | WATER PIK | WP-100/450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |