MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-17 for WATERPIK WATER FLOSSER WP-100 manufactured by Water Pik, Inc..
[26096560]
Testing of returned unit showed pressures in normal range. Product operated normally.
Patient Sequence No: 1, Text Type: N, H10
[26096561]
Per the customer.... Claims use at maximum pressure caused discoloration and painful inflammation of the gums. Customer alleges use of water flosser pushed bacteria into gumline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2015-00005 |
| MDR Report Key | 5085106 |
| Report Source | CONSUMER |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2015-09-17 |
| 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 | 2015-09-17 |
| Returned To Mfg | 2015-09-01 |
| Model Number | WP-100 |
| Lot Number | 140402 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-09-17 |