MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; PRESTIGE 9900 TOOTHBRUSH

Model Number HX9990

Device Problem Excessive Heating (4030)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to confirm a malfunction has occurred.

Event Description

It was reported that the charger was very hot and caused minor damage to the floor and skin irritation.

• Brand Name: PHILIPS SONICARE
• Type of Device: PRESTIGE 9900 TOOTHBRUSH
• 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: ellen patterson ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 18035665
• MDR Text Key: 326942044
• Report Number: 3026630-2023-00082
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX9990
• Device Catalogue Number: HX9990/12
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2021
• 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