MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-07-24 for PHILIPS SONICARE HX8140 manufactured by Philips Oral Healthcare.
[114939945]
Model and serial numbers provided are for airfloss handle. The incident occurred on the charger which is an accessory. The serial number of the charger was not provided. Complaint received from the (b)(6). Device manufacturing date not available due to the charger not being returned.
Patient Sequence No: 1, Text Type: N, H10
[114939946]
Consumer called stating that their airfloss charger caught on fire. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026630-2018-00338 |
| MDR Report Key | 7715828 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-07-24 |
| 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 | MS. TERRI BAUER-RIZZO |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254828498 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SONICARE |
| Generic Name | AIRFLOSS CHARGER |
| Product Code | EFS |
| Date Received | 2018-07-24 |
| Model Number | HX8140 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-24 |