MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for WATERPIK WATER FLOSSER WP-100 manufactured by Water Pik, Inc..
[38002993]
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
[38002994]
Per the customer.... Claims use of product has caused an abcess in her gum. Claims inadequate drainage of the water pathway allowed bacteria to develop in the unit and alleges this bacteria was forced into her gums. She describes a visible buildup as occurring in the handle assembly. She says a typical use cycle consists of using the classic jet tip at pressure settings varying from 3-5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2016-00002 |
| MDR Report Key | 5427387 |
| Date Received | 2016-02-10 |
| Date of Report | 2016-02-10 |
| Date of Event | 2016-02-05 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2011-10-08 |
| Date Added to Maude | 2016-02-10 |
| 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 | 0 |
| Brand Name | WATERPIK WATER FLOSSER |
| Generic Name | ORAL IRRIGATOR |
| Product Code | EFS |
| Date Received | 2016-02-10 |
| Model Number | WP-100 |
| Lot Number | JX11J08 |
| 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 | 2016-02-10 |