MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; DIAMONDCLEAN SMART ACCESSORY CHARGER

Model Number HX992B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

The event date is approximate.The consumer phone number was not provided.The complaint was received from a consumer in the netherlands.Product was not returned to confirm a malfunction has occurred.

Event Description

A consumer reported that while opening their parcel, a glass splinter from the diamondclean smart accessory charger got stuck in their finger.The consumer went to their general practitioner doctor whom recommended surgical intervention be required to remove the glass from the finger.Three contact attempts were made to the consumer to gather more information regarding this incident.No further information was provided as the consumer was not able to be reached.This case is being reported the based on the initial information provided.

• Brand Name: PHILIPS SONICARE
• Type of Device: DIAMONDCLEAN SMART ACCESSORY 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: imke overdevest ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 16504541
• MDR Text Key: 310899098
• Report Number: 3026630-2023-00013
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HX992B
• Device Catalogue Number: HX9917/89
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2022
• 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
• Patient Outcome(s): Required Intervention