MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-11-14 for PHILIPS SONICARE HX8240 manufactured by Philips Oral Healthcare.
[92017787]
Lacerations on the tongue made lead to permanent damage to a body structure.
Patient Sequence No: 1, Text Type: N, H10
[92017788]
Consumer complained the stream of the airfloss caused bleeding and a blood blister on their tongue. Medical attention sought.
Patient Sequence No: 1, Text Type: D, B5
[108298255]
Internal inspection shows no issue with unit. Charger is operating within specification. There is a warning in the dfu under important, caution on pg. 8 that states, "to avoid physical injury, do not direct the spray under the tongue or into the ear, nose, eye or other sensitive area. " the root cause of the customer's complaint could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3026630-2017-00280 |
| MDR Report Key | 7030401 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-11-14 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2018-01-03 |
| Device Manufacturer Date | 2017-07-12 |
| Date Added to Maude | 2017-11-14 |
| 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 | MS. NICOLE FLAVELL |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980413003 |
| Manufacturer Country | US |
| Manufacturer Postal | 980413003 |
| Manufacturer Phone | 4259081225 |
| Manufacturer G1 | PHILIPS ORAL HEALTHCARE |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980413003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 980413003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS SONICARE |
| Generic Name | AIRFLOSS 1.5 |
| Product Code | EFS |
| Date Received | 2017-11-14 |
| Returned To Mfg | 2018-01-03 |
| Model Number | HX8240 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ORAL HEALTHCARE |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 980413003 US 980413003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-14 |