MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-11 for PHILIPS SONICARE HX8340 manufactured by Philips Oral Healthcare.
[105324397]
Device manufacturing date not available due to the airfloss not being returned.
Patient Sequence No: 1, Text Type: N, H10
[105324398]
Consumer called stating that the nozzle from their airfloss pro/utra came off the handle and almost went down their throat. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[119228021]
Additional products returned were evaluated and found to not have any defects or malfunctions: part number: date code: description: hx6100 170412 2b triton base charger; hx803x 170620-01 af 2. 0 interdental nozzle (nozzle #1); hx803x 170620-01 af 2. 0 interdental nozzle (nozzle #2). The root cause of the customer's complaint could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[119228264]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3026630-2018-00305 |
| MDR Report Key | 7422576 |
| Report Source | CONSUMER |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-07 |
| Date of Event | 2018-04-07 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-08-08 |
| Date Added to Maude | 2018-04-11 |
| 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. TERRI BAUER-RIZZO |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254828498 |
| 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 PRO/ULTRA |
| Product Code | EFS |
| Date Received | 2018-04-11 |
| Returned To Mfg | 2018-05-08 |
| Model Number | HX8340 |
| 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 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |