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

Model Number HX684B

Device Problem Temperature Problem (3022)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

A consumer reported that their protective clean power toothbrush exploded.Some burnt marks on the carpet, and no injury were reported.

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.

Manufacturer Narrative

D4: the device serial numbers or manufacturing numbers were identified and updated.H4: manufacture date was identified and updated.Analysis results: the cause of the customer¿s complaint was a short circuit.

• Brand Name: PHILIPS SONICARE
• Type of Device: PROTECTIVECLEAN 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: chieu yeung ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 13233562
• MDR Text Key: 285041851
• Report Number: 3026630-2022-00006
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HX684B
• Device Catalogue Number: HX6850/57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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