FDA Adverse Event Malfunction Summary report: N

UNKNOWN

MDR report key: 8751321 · Received July 1, 2019

Report

Report Number: 3026630-2019-00048
Event Type: Malfunction
Date Received: July 1, 2019
Date of Event: June 4, 2019
Report Date: July 1, 2019
Product Code: JEQ
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

ORIGINAL "BECOME AWARE DATE" WAS 06/05/2019. ADDITIONAL INFORMATION RECEIVED 07/01/2019. THE PRODUCT WAS SOLD TO THE CONSUMER BRANDED AS A PHILIPS SONICARE TOOTHBRUSH BRUSH HEAD HOWEVER THE PRODUCT WAS DETERMINED TO BE COUNTERFEIT. 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. IT IS NOT KNOWN HOW THE COUNTERFEIT PRODUCT WAS MANUFACTURED AND WHETHER OR NOT IT WAS REPROCESSED. THE REPORTING MANUFACTURER IS PHILIPS ORAL HEALTHCARE. PHILIPS ORAL HEALTHCARE DID NOT MANUFACTURE THE PRODUCT THAT WAS RETURNED FOR ANALYSIS. THE COMPLAINT CAME FROM A CONSUMER IN THE (B)(6). THE ACTUAL DATE OF MANUFACTURE IS NOT KNOWN AT THIS TIME AS THE PRODUCT HAS BEEN IDENTIFIED AS COUNTERFEIT. THE PRODUCT WAS MARKETED TO THE CONSUMER AS A REUSABLE REPLACEMENT BRUSH HEAD. ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT A COUNTERFEIT BRUSH HEAD WAS IDENTIFIED AS THE ROOT CAUSE OF THE CONSUMER'S COMPLAINT.

Description of Event or Problem · 1

CONSUMER STATED THAT THEIR TOOTHBRUSH HEAD SNAPPED OFF DURING USE CAUSING A POTENTIAL CHOKING HAZARD. NO SERIOUS INJURIES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
544991	UNKNOWN	UNKNOWN	JEQ

Patients

Seq	Age	Sex	Outcome	Treatment
1