MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for PHILIPS SONICARE DIAMONDCLEAN REPLACEMENT TOOTHBRUSH HEAD HX6064/64 manufactured by Philips Austria Gmbh.
[182221425]
After using my philips sonicare electric toothbrush, i notice a brown liquid come out of the detachable brush head. I've used sonicare for several years and this has never happened before, but it happened repeatedly with this brush head over three weeks. I no longer use the brush head. It is definitely traceable to the brush head, as the issue moves with the brush head between two electric toothbrush handles, and no other brush heads that i own have the issue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093499 |
| MDR Report Key | 9785798 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SONICARE DIAMONDCLEAN REPLACEMENT TOOTHBRUSH HEAD |
| Generic Name | TOOTHBRUSH POWERED |
| Product Code | JEQ |
| Date Received | 2020-03-03 |
| Model Number | HX6064/64 |
| Catalog Number | HX6064/64 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS AUSTRIA GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |