FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes

April 23, 2012 |  Print  | Share/Bookmark  | 4 responses

Date Issued: Feb. 16, 2012

Audience:

• Consumers who use or may purchase the Crest and/or Arm & Hammer Spinbrush
• Parents and caregivers who use or may purchase the Crest and/or Arm & Hammer Kid’s Spinbrush
• Health care professionals including dentists, dental hygienists and dental assistants who recommend the Crest and/or Arm & Hammer Spinbrush

Medical Specialty: Pediatrics, Dentistry

Device:

A battery-powered toothbrush is a device with a motorized handle that provides movement to a brush head for the removal of plaque and food debris.

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. For the purpose of this communication, Spinbrush will refer to both the Arm & Hammer and Crest Spinbrush lines of powered toothbrushes.

Purpose:

The FDA is issuing this communication to alert parents, caregivers, consumers and dental care professionals about serious injuries and unexpected hazards with the use of all models of the Spinbrush.

Summary of Problem and Scope:

The FDA is aware of reports of serious injuries and potential hazards associated with the use 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.

Recommendations to Parents, Caregivers and Consumers:

Church & Dwight Co., Inc has issued the following safety notice regarding the use of the Spinbrush powered toothbrushes:

“Please remember to replace your brush head after 3 months of use, or if the brush is damaged or if parts become loose. Extended usage, loose parts or excessive wear could lead to brush head breakage, generation of small parts and possible choking hazard. Inspect the brush for loose parts before use.”

The FDA supports Church & Dwight Co., Inc.’s safety message, and also 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.
• Follow the instructions and recommended replacement guidelines included with the Spinbrush.

◦                                  NOTE: The brush head for the Kid’s Spinbrush is not replaceable. If you notice any damage or loose brush bristles, DO NOT USE.

FDA Activities:

• On May 16, 2011 the FDA issued a Warning Letter to Church & Dwight Co., Inc. for violations including failure to file Medical Device Reports for serious injuries within a reasonable timeframe.
• On Dec 22, 2011, Church & Dwight Co., Inc. issued a safety notice on the potential brush head breakage hazard. The firm has also added “color-wear” bristles to newly manufactured brushes to provide consumers with a visual reminder to change the brush head every three months.
• On Jan.25, 2012, the FDA posted Church & Dwight Co., Inc.’s. Class II recall of various models of their Spinbrush line of powered toothbrushes to help communicate the potential choking hazard if the Spinbrush is used beyond the recommended 3-month brush head life.
• The FDA will continue to monitor adverse events associated with the use of the Spinbrush and will make available any new information that might affect the use of this device.

Additional Resources

• FDA Consumer Update – Toothbrush Can Chip Teeth and Cause Choking
• Church & Dwight Co., Inc. – Spinbrush Safety Notice
• Class II Recall: Spinbrush Pro-Clean (posted Jan. 25, 2012)
• Class II Recall: Spinbrush Pro Whitening (posted Jan. 25, 2012)
• Class II Recall: Spinbrush Pro Clean Re-Charge (posted Jan. 25, 2012)

Reporting Problems to the FDA:

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 MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Please include the following information, if available, in your report:

• Manufacturer and distributor names
• Brand name of the device
• Age of the device and brush head
• A detailed account of the event as well as relevant descriptions of what occurred before and after the event
• Relevant patient medical history

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Accessed: April 22, 2012 www.FDA.gov

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm291866.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=spinbrush&utm_content=1#.T5Qf95vPaVw.email