FDA Adverse Event Malfunction Summary report: N

ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

MDR report key: 4853072 · Received May 27, 2015

Report

Report Number: 3000302531-2015-00184
Event Type: Malfunction
Date Received: May 27, 2015
Report Date: April 29, 2015
Manufacturer: BRAUN GMBH WERK MARKTHEIDENFELD
Product Code: JEQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

RETURN OF PROD HAS BEEN REQUESTED. PROD NOT PROVIDED BY REPORTER, THEREFORE UNABLE TO PROCEED WITH PROD INVESTIGATION AT THIS TIME. FULL EVAL WILL OCCUR UPON RECEIPT OF RETURNED PROD.

Additional Manufacturer Narrative · 1

(B)(4)-2015: PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED 1 TOOTHBRUSH HEAD. TOOTHBRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

Description of Event or Problem · 1

METAL PIN CAME LOOSE AND THEN THE BRUSH HEAD FELL APART [DEVICE BREAKAGE], NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A (B)(6) YEAR OLD FEMALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK, THE METAL PIN CAME LOOSE FROM THE ORAL-B PRECISION CLEAN BRUSHHEAD AND THE BRUSH HEAD FELL APART. NO SYMPTOMS DEVELOPED.

Description of Event or Problem · 1

PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. METAL PIN CAME LOOSE AND THEN THE BRUSH HEAD FELL APART [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED THAT WHILE USING AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE METAL PIN CAME LOOSE FROM THE ORAL-B PRECISION CLEAN BRUSHHEAD AND THE BRUSH HEAD FELL APART. NO SYMPTOMS DEVELOPED. ON 02-JUN-2015 PRODUCT INVESTIGATION: THE SUSPECT PRODUCT IN THIS CASE WAS CONFIRMED TO BE COUNTERFEIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
344757	ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS	TOOTHBRUSH HEAD REFILL	JEQ	BRAUN GMBH WERK MARKTHEIDENFELD	EB17

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR