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

Model Number HX903X

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/29/2021

Event Type  Injury  

Event Description

A consumer reported that their (b)(6) brush head damaged their gum.

Manufacturer Narrative

Outcomes attributed to adverse event: the reported adverse event was gum damaged.Date of event is approximate.The device serial numbers or manufacturing numbers were not provided.The reporter contact address and phone number were not provided.Manufacture date not provided or identifiable.

Manufacturer Narrative

E1: the consumer mailing address was identified and updated.Analysis results: product was not returned to confirm a malfunction has occurred.H3 other text : product not returned to manufacturer.

Manufacturer Narrative

Analysis results: the cause of the customers complaint is molded hard plastic in the bristle field.

Manufacturer Narrative

G9: correction of mfr report number cfn/fei # from 3019216 to 3026630.

• Brand Name: PHILIPS SONICARE
• Type of Device: PRORESULTS 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: chieu yeung ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 12791814
• MDR Text Key: 280680942
• Report Number: 3019216-2021-10146
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HX903X
• Device Catalogue Number: HX6423/34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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): Other