PHILIPS SONICARE HX8240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-17 for PHILIPS SONICARE HX8240 manufactured by Philips Oral Healthcare.

Event Text Entries

[89561295] Loosening of a recemented crown may lead to permanent damage of a body structure.
Patient Sequence No: 1, Text Type: N, H10

[89561296] Consumer complained the stream of the airfloss made their gums bleed and loosened a re-cemented crown.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3026630-2017-00194
• MDR Report Key: 6956643
• Report Source: CONSUMER
• Date Received: 2017-10-17
• Date of Report: 2017-10-13
• Date of Event: 2017-10-03
• Date Mfgr Received: 2017-11-29
• Device Manufacturer Date: 2013-08-14
• Date Added to Maude: 2017-10-17
• 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

Device Details

• Brand Name: PHILIPS SONICARE
• Generic Name: AIRFLOSS HANDLE
• Product Code: EFS
• Date Received: 2017-10-17
• Returned To Mfg: 2017-11-29
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-10-17