FDA Adverse Event Malfunction Summary report: N

ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH

MDR report key: 5350181 · Received January 7, 2016

Report

Report Number: 3000302531-2016-00007
Event Type: Malfunction
Date Received: January 7, 2016
Report Date: December 8, 2015
Manufacturer: BRAUN GMBH WERK MARKTHEIDENFELD
Product Code: JEQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

Description of Event or Problem · 1

JABS CHEEK [MOUTH INJURY], BRUSH HEAD COMES LOOSE AND JABS CHEEK [INJURY ASSOCIATED WITH DEVICE], BRUSH HEAD COMES LOOSE/ COMES OFF [DEVICE BREAKAGE]. CASE DESCRIPTION: A MALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE TRIUMPH 3738, THE ORAL-B BRUSHHEADS, VERSION UNKNOWN, AND THE ORAL-B DUAL CLEAN BRUSHHEADS BOTH COME LOOSE, AND SOMETIMES THE METAL ROD JABS HIM IN THE CHEEK WHEN THE BRUSH HEAD COMES OFF. HE REPORTED THAT HE HAD THE TOOTHBRUSH FOR QUITE A WHILE, BUT HE HAD RECENTLY STARTED USING IT. IT WAS RUNNING SLOWER THAN IT DID AT FIRST. THE CASE OUTCOME WAS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
10401	ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH	TOOTHBRUSH, POWERED	JEQ	BRAUN GMBH WERK MARKTHEIDENFELD

Patients

Seq	Age	Sex	Outcome	Treatment
1