MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-16 for WATERPIK manufactured by .
[22046649]
The waterpik sinusense combines water and battery compartment together causing corrosion which is then pulsated in to the nasal and sinus cavity. I bought this product to use after sinus surgery and i have had complications as many others have had. Msds sheet for batteries included with product list lead and mercury. Please investigate their negligence before anyone else is exposed to these dangerous chemicals. Dates of use: (b)(6) 2012. Event ablated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024670 |
| MDR Report Key | 2498052 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-02-10 |
| Date Added to Maude | 2012-03-22 |
| 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 |
| Product Code | EFS |
| Date Received | 2012-03-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-03-16 |