MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-16 for WATER PIK WP-100W/WP-100C manufactured by Water Pik.
[2757217]
On (b)(6) 2012, the consumer was using the water pik flosser on her upper right back teeth when the flosser automatically went on full pressure. The flosser slipped from her hand and ripped the skin from the inside of her jaw. She stated that this is the first time that it happened. On (b)(6) 2012, the consumer stated that it would not stop bleeding so she called her dentist and was advised to rinse her mouth in salt water. The consumer stated that she later discovered a mass amount of loose skin where her inside jaw was ripped. The consumer stated that she called the retailer ((b)(4)) and was told to bring the product in for a new one. She did not contact the mfr but will in the future. Purchase date: (b)(6) 2012. The product was not damaged or modified before the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026761 |
| MDR Report Key | 2727096 |
| Date Received | 2012-08-16 |
| Date of Report | 2012-08-16 |
| Date of Event | 2012-08-12 |
| Date Added to Maude | 2012-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER PIK |
| Generic Name | WATER FLOSSER |
| Product Code | EFS |
| Date Received | 2012-08-16 |
| Model Number | WP-100W/WP-100C |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER PIK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-16 |