MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PROTECTIVECLEAN BRUSH HEAD

Model Number HX682P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date is approximate.Product was not returned to confirm a malfunction has occurred.Product not returned to manufacturer.

Event Description

A consumer reported that the protective clean brush head broke into pieces during use.No serious injury or medical intervention was reported.A possible choking hazard was identified.

Event Description

On 03/07/2023, further investigation of this case has determined that the alleged product is a non-authentic philips device.This was confirmed by investigation by the philips clinical and product inspection team experts with the photos provided by the consumer.This case is now determined to be not reportable.

Manufacturer Narrative

On 03/07/2023, it was determined that the product alleged is a non-authentic philips device.This case is now determined to be not reportable.Reportability for initial mfr report number 3026630-2023-00011 submitted on 02/28/2023 can be removed.

• Brand Name: PHILIPS SONICARE
• Type of Device: PROTECTIVECLEAN BRUSH HEAD
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: imke overdevest ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 16457181
• MDR Text Key: 310403093
• Report Number: 3026630-2023-00011
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX682P
• Device Catalogue Number: HX6829/71
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1