This Allert Issure by FDA MED Watch: The Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries

AUDIENCE: Comsumer, Dentist

ISSUE: FDA notified parents, caregivers, consumers, and dental care professionals about reports of serious injuries and potential hazards associated with the use of all models of the Spinbrush. These reports indicated that while turned on, the brush head has either “popped off” or broken off in the user’s mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes. When the unexpected release of any part of the powered toothbrush occurs, there is a potential for serious injury. This risk is higher for unattended children or adults who may need assistance while using this device.

BACKGROUND: The Spinbrush line of powered toothbrushes is currently sold as the Arm & Hammer Spinbrush and until 2009 was sold as the Crest Spinbrush. The Spinbrush line is manufactured by Church & Dwight Co., Inc.

RECOMMENDATIONS: FDA recommends that consumers:

• Inspect the Spinbrush for any damage or loose brush bristles prior to using. If you notice any damage or loose brush bristles, DO NOT USE.
• Check to be sure that the headpiece is connected properly to the handle of the brush and test your brush outside of the mouth prior to using. If you notice the connection feels loose or the headpiece easily detaches from the handle, DO NOT USE.
• Supervise children and adults who need assistance when using the Spinbrush.
• Do not bite down on the brush head while brushing.

See the FDA Safety Communication for FDA/manufacturer recommendations and product photos.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a Spinbrush, we encourage you to file a voluntary report through FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MeDWatch safety alert, including links to the Safety Communication and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292239.htm