MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-03 for PHILIPS SONICARE HX8340 HX8331/11 manufactured by Philips Oral Healthcare, Llc.
[189093904]
The event date is approximate. Report source: complaint received from (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[189093905]
A consumer reported that their sonicare airfloss exploded while charging. No injury or property damage was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026630-2020-00009 |
| MDR Report Key | 9661914 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-03 |
| Date of Event | 2020-01-28 |
| Date Facility Aware | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2020-02-03 |
| 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. CHIEU YEUNG |
| Manufacturer Street | 22100 BOTHELL EVERETT HIGHWAY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254877000 |
| Manufacturer G1 | PHILIPS ORAL HEALTHCARE, LLC |
| Manufacturer Street | 22100 BOTHELL EVERETT HIGHWAY |
| 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 PRO |
| Product Code | EFS |
| Date Received | 2020-02-03 |
| Model Number | HX8340 |
| Catalog Number | HX8331/11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ORAL HEALTHCARE, LLC |
| Manufacturer Address | 22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |