MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-24 for WATERPIK WATER FLOSSER WP-360 manufactured by Water Pik, Inc..
[26683306]
Unit in question has not yet been returned for testing and evaluation.
Patient Sequence No: 1, Text Type: N, H10
[26683307]
Per the customer.... Father claims the (b)(6) daughter injured the roof of her mouth while flossing. Says daughter has used her wp-360 for some time with the high pressure tip and has had no problems. Suddenly the pressure became much higher than usual and caused small abrasions on the roof of her mouth. Daughter has braces, did not receive medical attention and abrasions healed quickly. Customer requested a replacement unit.
Patient Sequence No: 1, Text Type: D, B5
[31706083]
Returned unit tested and found to be within the normal operating pressure range and was operating as designed. There is no known situation where pressure can temporarily increase. Most likely situation is that customer aimed water jet at soft tissue instead of gum area and caused pain. This is warned against in the product instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[31706084]
Per the customer.... Father claims the (b)(6) year old daughter injured the roof of her mouth while flossing. Says daughter has used her wp-360 for some time with the high pressure tip and has had no problems. Suddenly the pressure became much higher than usual and caused small abrasions on the roof of her mouth. Daughter has braces, did not receive medical attention and abrasions healed quickly. Customer requested a replacement unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2015-00006 |
| MDR Report Key | 5101391 |
| Report Source | CONSUMER |
| Date Received | 2015-09-24 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2012-03-16 |
| Date Added to Maude | 2015-09-24 |
| 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 | 2015-09-24 |
| Returned To Mfg | 2015-10-15 |
| Model Number | WP-360 |
| Lot Number | KL120316GA |
| 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 | 2015-09-24 |