MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-06 for WATERPIK WATER FLOSSER WP-140 manufactured by Water Pik, Inc..
[56589909]
Unit in question has not yet been returned for testing and evaluation. Device in question has not been received.
Patient Sequence No: 1, Text Type: N, H10
[56589910]
Per the customer.... Claims to have sustained injury at the time of initial use, unit was set to maximum pressure setting to prime as per product literature. Customer did not lessen pressure when attempting to use the product and claims to have experienced bleeding gums. Customer claims bacterial pneumonia/infection were sustained due to use of the product. Customer acknowledges that the product was not used as instructed. Customer emailed her dentist, the dentist wrote back and told her that she probably did not use the device correctly and did not agree with her self-diagnosis about the bacterial infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2016-00004 |
| MDR Report Key | 6002891 |
| Report Source | CONSUMER |
| Date Received | 2016-10-06 |
| Date of Report | 2016-10-05 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2016-09-22 |
| Date Added to Maude | 2016-10-06 |
| 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 | 2016-10-06 |
| Model Number | WP-140 |
| 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 | 2016-10-06 |