inforMED
MalfunctionJEQ

ORALBPWRBATTTOOTHBRUSHHANDLE4732CROSSACTNPWR

Received Aug 12, 2019

Report 3000302531-2019-00148 · MDR key 8882988

Device

Generic name

Toothbrush, Powered

Model number

4732

Lot number

548

Product problems

  • Detachment of Device or Device Component

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS AN ORAL-B POWER BATTERY TOOTHBRUSH HANDLE 4732 CROSS ACTION POWER. 05-DEC-2019 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND INVESTIGATED. PRODUCT INVESTIGATION RESULTS SHOWED THAT THE COMPLAINT IS CAUSED BY WEAR OF THE DRIVING SHAFT DUE TO USAGE OF ABRASIVE TOOTHPASTE IN COMBINATION WITH INSUFFICIENT CLEANING WITH USE OVER MANY YEARS.

Description of Event or Problem

CONSUMER CONTACTED VIA PHONE AND STATED THAT THE WHOLE BRUSH HEAD KEPT COMING OFF IN HIS/HER MOUTH. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

Description of Event or Problem

CONSUMER CONTACTED VIA PHONE AND STATED THAT THE WHOLE BRUSH HEAD KEPT COMING OFF IN HIS/HER MOUTH. NO INJURY WAS REPORTED.