FDA Adverse Event Other Summary report: N

SONICARE

MDR report key: 3592663 · Received January 8, 2014

Report

Report Number
3026630-2013-00033
Event Type
Other
Date Received
January 8, 2014
Date of Event
December 17, 2013
Report Date
December 31, 2013
Manufacturer
PHILIPS ORAL HEALTHCARE
Product Code
JEQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2013, CUSTOMER CLAIMS WHEN USING TOOTHBRUSH THAT THE HANDLE WAS VIBRATING IRREGULARLY AND HIT HIS TWO FRONT WHICH CAUSED THEM TO CHIP. REQUESTED THAT THE UNIT BE RETURNED FOR EVAL. ON (B)(4) 2013, REQUEST FOR DENTAL INFO IN RELATION TO THIS CLAIMED INCIDENT WS SENT TO THE CONSUMER.

Description of Event or Problem · 1

ON (B)(6) 2013, CUSTOMER CLAIMS HE CHIPPED TWO TEETH USING THE UNIT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
14843 SONICARE FLEXCARE JEQ PHILIPS ORAL HEALTHCARE HX6950

Patients

Seq Age Sex Outcome Treatment
1 UNK Other