MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; EXPERTRESULTS POWER TOOTHBRUSH

Model Number HX751V

Device Problem Overheating of Device (1437)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/08/2023

Event Type  Injury  

Event Description

A consumer reported that an expertresults power toothbrush exploded which caused acid to get on the hands.No further information regarding outcome of the minor injury was reported.No serious injury was reported.

Manufacturer Narrative

The event date is approximate.The consumer contact information, mailing address, phone number were not provided.Product was not returned to confirm a malfunction has occurred.

• Brand Name: PHILIPS SONICARE
• Type of Device: EXPERTRESULTS POWER 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: imke overdevest ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 16649869
• MDR Text Key: 312405044
• Report Number: 3026630-2023-00026
• 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: HX751V
• Device Catalogue Number: HX7533/03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2018
• 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