MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for SONICARE HX8340 manufactured by Philips Oral Healthcare.
[75404047]
Patient Sequence No: 1, Text Type: N, H10
[75404048]
Customer stated the product was not working well so she didn't use it often. She said 2 weeks ago she lost her tooth and shortly after got it replaced. Customer says the reason she didn't use it often is because of the condition of her teeth. She is accepting of some of the blame but states she intended on sending the product back before incident ever happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026630-2017-00044 |
| MDR Report Key | 6573425 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-05-17 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH CONLISK |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4259081303 |
| Manufacturer G1 | PHILIPS ORAL HEALTHCARE |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SONICARE |
| Generic Name | HX8340 AIRFLOSSPRO/ULTRA |
| Product Code | EFS |
| Date Received | 2017-05-17 |
| Model Number | HX8340 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ORAL HEALTHCARE |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-17 |