MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-01 for WATERPIK WATER FLOSSER WP-310 manufactured by Water Pik, Inc..
[76422443]
Unit in question has not been returned for testing and evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76422564]
Per the customer.... While using the wp-310 with the clear jet-tip on pressure setting 2, two of his teeth popped out. He stated he was using the water flosser with the tip pointed at a 90 degree angle. Customer stated that this happened about a month ago, he went to the dentist about a week after the incident. He indicated that the teeth 9 and 10 popped out, since they were glued together. The dentist stated he would need repair for either a bridge or implant to fix his teeth. He is looking to get monetary assistance to repair his teeth. Customer said that he would send product back for analysis.
Patient Sequence No: 1, Text Type: D, B5
[118005858]
Returned product was pressure tested and found to operate within normal pressure range.
Patient Sequence No: 1, Text Type: N, H10
[118005859]
Per the customer.... While using the wp-310 with the clear jet-tip on pressure setting 2, two of his teeth popped out. He stated he was using the water flosser with the tip pointed at a 90 degree angle. Customer stated that this happened about a month ago, he went to the dentist about a week after the incident. He indicated that the teeth 9 and 10 popped out, since they were glued together. The dentist stated he would need repair for either a bridge or implant to fix his teeth. He is looking to get monetary assistance to repair his teeth. Customer said that he would send product back for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2017-00003 |
| MDR Report Key | 6604709 |
| Report Source | CONSUMER |
| Date Received | 2017-06-01 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2017-06-01 |
| 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 | 2017-06-01 |
| Returned To Mfg | 2017-06-09 |
| Model Number | WP-310 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-06-01 |