MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-02 for PHILIPS SONICARE HX8431 manufactured by Philips Oral Healthcare.
[143917552]
The consumer alleges that they lost a filling from their teeth. Event date is approximate. The serial number is not available because the product was not returned. The product was discarded by the consumer and will not be returned to the manufacturer. Foreign: complaint received from (b)(6). The product was discarded by the consumer and will not be returned to the manufacturer. The manufacturing date is not available because the product was not returned.
Patient Sequence No: 1, Text Type: N, H10
[143917553]
Consumer alleges that they lost a filling from their teeth when using their sonicare airfloss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026630-2019-00032 |
| MDR Report Key | 8576016 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-02 |
| 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 | SARA MARIEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254828259 |
| 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 ULTRA |
| Product Code | EFS |
| Date Received | 2019-05-02 |
| Model Number | HX8431 |
| 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 |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |