MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04,07 report with the FDA on 2009-10-22 for SONICAR FLEXCARE INTEGRATED SANITIZER HX6150 4235 010 07230 manufactured by Philips Oral Healthcare.
[1326848]
The consumer saw smoke coming out of his bathroom; it happened around eleven in the evening. It was not being used. The uv light sanitizer failed, melting from the top of the unit. The unit left black markings in the area around the failed unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026630-2009-00002 |
| MDR Report Key | 1517835 |
| Report Source | 00,01,04,07 |
| Date Received | 2009-10-22 |
| Date of Report | 2009-10-22 |
| Date of Event | 2009-09-23 |
| Date Mfgr Received | 2009-09-24 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2010-03-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA GARRETT |
| Manufacturer Street | 35301 S.E. CENTER ST. |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 4253962525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICAR FLEXCARE INTEGRATED SANITIZER |
| Generic Name | UNIT, ULTRAVIOLET SANITATION/STERILIZATION |
| Product Code | NOB |
| Date Received | 2009-10-22 |
| Returned To Mfg | 2009-10-20 |
| Model Number | HX6150 |
| Catalog Number | 4235 010 07230 |
| Lot Number | 0749 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ORAL HEALTHCARE |
| Manufacturer Address | SNOQUALMIE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-22 |