MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC UNKNOWN; CHARGER

Model Number HX9100

Device Problems Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

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

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate.The issue is reported to be with the accessory charger of the diamondclean power toothbrush system.The complaint was received from a consumer in (b)(6).

Event Description

A consumer reported that their diamondclean power toothbrush charging glass exploded.No property damage and no injury were reported.

Manufacturer Narrative

D1-d4: the product was returned to philips oral healthcare at bothell and failure analysis was performed and determined to be non authentic philips product.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.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 not authentic philips product.H5: it is unknown how the counterfeit product labeled for single use or not.Analysis results: on 06/14/2022, the returned product was performed at philips oral healthcare lab and failure analysis identified that charger was not an authentic philips product as the cause of the consumer's complaint.Therefore, this case was re-reviewed and deemed to be not reportable.

Event Description

A consumer reported that their diamondclean power toothbrush charging glass exploded.No property damage and no injury were reported.06/14/2022, the returned product was performed at philips oral healthcare lab and failure analysis identified that charger was not an authentic philips product as the cause of the consumer's complaint.Therefore, this case was re-reviewed and deemed to be not reportable.

• Brand Name: UNKNOWN
• Type of Device: CHARGER
• 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: 14062454
• MDR Text Key: 289878073
• Report Number: 3026630-2022-00036
• 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: HX9100
• Device Catalogue Number: HX9355/86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1