MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-08 for WATERPIK WATER FLOSSER WP-100PLT manufactured by Water Pik, Inc..
[5841730]
Per the customer.... "used the wp-100plt friday (b)(6) 2015 in the front near the bridge on top of the mouth. The hose split during use, scared her. Took the tip out of mouth and part of bridge or crown came out. Must have happened when the hose broke and maybe banged it into her tooth and broke the bridge or crown. "
Patient Sequence No: 1, Text Type: D, B5
[13346904]
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
[24663883]
Inspection of returned unit showed that the irrigator hose was broken below the handle. The hose material was brittle and could easily be broken in the area below the handle and involving the first coil of the hose. The remainder of the hose coils were flexible and normal. It appears that the hose material was attached and degraded by a chemical. This may have been a medicament that ran down the handle/hose during use or it may have been due to over spray from a material such as hair spray.
Patient Sequence No: 1, Text Type: N, H10
[24663884]
Per the customer.... "used the wp-100plt friday (b)(6) 2015 in the front near the bridge on top of the mouth. The hose split during use, scared her. Took the tip out of mouth and part of bridge or crown came out. Must have happened when the hose broke and maybe banged it into her tooth and broke the bridge or crown. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001712259-2015-00003 |
| MDR Report Key | 4825156 |
| Report Source | 04 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-05-18 |
| Date Mfgr Received | 2015-05-18 |
| Device Manufacturer Date | 2014-07-17 |
| Date Added to Maude | 2015-06-08 |
| 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 | 0 |
| Event Location | 0 |
| 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 G1 | WATER PIK, INC. |
| Manufacturer Street | 1730 EAST PROSPECT ROAD |
| Manufacturer City | FORT COLLINS CO 80553000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80553 0001 |
| 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 | 2015-06-08 |
| Returned To Mfg | 2015-06-25 |
| Model Number | WP-100PLT |
| Lot Number | JX111229A |
| 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 80553000 US 80553 0001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-08 |