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

Model Number HX993W

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

B3: the event date is approximate.G3: the complaint was received from a consumer in germany.H4: manufacture date not provided or identifiable.Product was not returned to confirm a malfunction has occurred.

Event Description

A consumer reported that a diamondclean smart power toothbrush caught fire.No injury or property damage was reported.

Event Description

Based on the available information, a correction is required.A minor injury was reported.No serious injury or medical intervention was reported.

Manufacturer Narrative

Patient outcome code grid- correction.Health impact grid- correction.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN SMART 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: 17337612
• MDR Text Key: 319256359
• Report Number: 3026630-2023-00054
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX993W
• Device Catalogue Number: HX9924/03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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