MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-07 for WATERPIK manufactured by Water Pik, Inc..
[1981307]
Waterpik has a nasal irrigation device that allows users to flush the sinuses. After a few weeks of use, i noticed brown rust like water coming out of my nose. Come to find out the device doesn't seal properly and allows water to enter into the battery compartment. I requested a replacement and waterpik was more than happy to replace my "defective" unit. After a few weeks of using the new one i had the same issue with rusty battery water. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020549 |
| MDR Report Key | 2088200 |
| Date Received | 2011-05-07 |
| Date of Report | 2011-05-07 |
| Date of Event | 2011-02-02 |
| Date Added to Maude | 2011-05-18 |
| 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 | WATERPIK |
| Generic Name | SINUSENSE WATER PULSATOR |
| Product Code | KMA |
| Date Received | 2011-05-07 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK, INC. |
| Manufacturer Address | 1730 E. PROSPECT RD. FORT COLLINS CO 80553 US 80553 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2011-05-07 |