MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, LLC PHILIPS SONICARE; SONIC TOOTHBRUSH HEAD

Catalog Number BRUSH HEADS

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2023

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 germany.Product was not returned to confirm a malfunction has occurred.H3 other text : product not returned to manufacturer.

Event Description

The consumer reported that the bristles of the brush head detached during brushing.Bristles were in her throat and the customer had to gargle to get them out.The customer then went to the doctor, where they were diagnosed after a laryngoscopy.Because it didn't get better, the customer then went to the doctor twice and was prescribed an anti-medication.The customer was then referred to a pulmonaryologist and a lung examination was performed under anesthesia.However was diagnosed and the customer stayed in the clinic.Follow up is still being performed and a supplemental will be filed if additional information is provided.This case is being reported based on the initial information provided.

Manufacturer Narrative

The customer reported: "bristles of the brush head detached during brushing." six brush heads were returned to ohc for failure analysis.One philips sonicare ptb handle was returned with the brush heads.Performed visual inspection of the returned brush heads observing the device is not a philips product.The returned brush heads are counterfeit.The sonicare branding font and overall form factor of the returned brush heads does not align with a genuine philips brush head.Additionally, the rfid chip in the returned brush head is a dummy non-functioning unit to mimic the appearance if an rfid chip.The serial numbers are also misaligned and off center.

Event Description

The customer reported "bristles of the brush head detached during brushing." the device was returned to ohc for failure analysis.Per failure analysis the issue reported was bristles of the brush head detached during brushing.Failure analysis concluded that the device is counterfeit.

• Brand Name: PHILIPS SONICARE
• Type of Device: SONIC TOOTHBRUSH 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: ellen patterson ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 18650435
• MDR Text Key: 334649710
• Report Number: 3026630-2024-00005
• 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

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: BRUSH HEADS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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