MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-20 for WATERPIK WATER FLOSSER WP-562 manufactured by Water Pik, Inc..
[111731407]
Unit in question has not been returned for testing and evaluation.
Patient Sequence No: 1, Text Type: N, H10
[111731408]
Per the customer.... Claims device failed during use, front faceplate popped off and handle is cracked open exposing pressure setting and charge indicator diodes. Customer denies any use of additives or potential for chemical attack or any other misuse. Customer identified this caused a mark on his hand and ears to ring but nothing more severe. He is not seeking restitution for any injury. Customer claims unit leaked after use from day one and describes the pump as inconsistent. Unit has been used since (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2018-00003 |
| MDR Report Key | 7620618 |
| Report Source | CONSUMER |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2017-09-29 |
| Date Added to Maude | 2018-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT VANDER VLIET |
| Manufacturer Street | 1730 EAST PROSPECT ROAD |
| Manufacturer City | FORT COLLINS CO 805530001 |
| Manufacturer Country | US |
| Manufacturer Postal | 805530001 |
| Manufacturer Phone | 9702217063 |
| Manufacturer G1 | WATER PIK, INC. |
| Manufacturer Street | 1730 EAST PROSPECT ROAD |
| Manufacturer City | FORT COLLINS CO 805530001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 805530001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERPIK WATER FLOSSER |
| Generic Name | ORAL IRRIGATOR |
| Product Code | EFS |
| Date Received | 2018-06-20 |
| Model Number | WP-562 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK, INC. |
| Manufacturer Address | 1730 EAST PROSPECT ROAD FORT COLLINS CO 805530001 US 805530001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-20 |