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

Model Number HX939B

Device Problems Mechanical Problem (1384); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

The event date is approximate.The device serial numbers or manufacturing numbers were not provided.The complaint was received from a consumer in (b)(6).Manufacture date not provided or identifiable.

Event Description

Customer report- their diamond clean charger has exploded.No patient injury and property damage reported.

Manufacturer Narrative

Analysis result: product was not returned to confirm a malfunction has occurred.H3 other text: product not returned to the manufacturer.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN POWER TOOTHBURSH
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11742359
• MDR Text Key: 248211088
• Report Number: 3026630-2021-10013
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX939B
• Device Catalogue Number: HX9396/89
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/27/2021
• Date Manufacturer Received: 04/30/2021
• Patient Sequence Number: 1