FDA Adverse Event Injury Summary report: N

PHILIPSSONICARE

MDR report key: 11158054 · Received January 12, 2021

Report

Report Number
3026630-2021-00005
Event Type
Injury
Date Received
January 12, 2021
Date of Event
November 30, 2020
Manufacturer
PHILIPS ORAL HEALTHCARE, LLC
Product Code
JEQ
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
003

Narratives

Additional Manufacturer Narrative · 0

D4: THE PRODUCT MODEL WAS IDENTIFIED AND UPDATED. ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT THE ROOT CAUSE WAS A DEFORMED CHARGER DUE TO CUSTOMER MISUSE.

Additional Manufacturer Narrative · 1

THE EVENT DATE IS APPROXIMATE. THE PRODUCT MODEL, CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, AND UDI WERE NOT PROVIDED. A PARTIAL SERIAL NUMBER WAS DETERMINED FROM PHOTOS PROVIDED BY THE CONSUMER. REPORT SOURCE: THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6).

Description of Event or Problem · 1

A CONSUMER REPORTED THAT THEIR PHILIPS CHARGER CAUGHT FIRE. NO SERIOUS INJURIES OR PROPERTY DAMAGE WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
49741 PHILIPSSONICARE SONICARE CHARGER JEQ PHILIPS ORAL HEALTHCARE, LLC 420303553940

Patients

Seq Age Sex Outcome Treatment
1