MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; SONICARE FOR KIDS BRUSH HEAD

Catalog Number HX6031/20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

A consumer reported that a small metal plate on a sonicare for kids brush head hurt the consumer.A minor injury was reported.No serious injury or medical intervention was reported.

Manufacturer Narrative

The event date is approximate.The complaint was received from a consumer in germany.Product was not returned to confirm a malfunction has occurred.

• Brand Name: PHILIPS SONICARE
• Type of Device: SONICARE FOR KIDS BRUSH HEAD
• 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: 15901545
• MDR Text Key: 304890870
• Report Number: 3026630-2022-00156
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HX6031/20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1