MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC UNKNOWN

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate.The specific product system was not provided.The product model #, catalog #, serial # and lot # were not provided.The sonicare power toothbrush charger is an accessory to the sonicare power toothbrush system.The complaint was received from a consumer in (b)(6).The manufacture date cannot be determined based on the provided information.

Event Description

The consumer reported that their sonicare power toothbrush charger has flame came out and caused the safety fuse turn off.No property damage reported.

Manufacturer Narrative

Analysis results: failure analysis of the returned product (performed at philips oral healthcare) identified that a counterfeit charger was identified as the root cause of the consumer's complaint.A2-a4: information not provided.D1-d4: the product was sold to the consumer branded as a philips sonicare toothbrush however the product was determined to be counterfeit.Therefore, no information is currently available describing the actual product brand name, product code, common device name, model number, serial number, or manufacturer contact information.The reporting manufacturer is philips oral healthcare.The actual manufacturer is unknown.D8: it is not known how the counterfeit product was manufactured.G1: the reporting manufacturer is philips oral healthcare.Philips oral healthcare did not manufacture the product that was returned for analysis.H4: the actual date of manufacture is not known at this time as the product has been identified as counterfeit.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11025089
• MDR Text Key: 222017824
• Report Number: 3026630-2020-00079
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Distributor Facility Aware Date: 11/23/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1