The alert specifies the battery-powered Arm & Hammer Spinbrush, known as the Crest Spinbrush prior to 2009, according to a consumer update from FDA Consumer Health Information.
"It's important that consumers know how to avoid the risks associated with using the Spinbrush," said Shumaya Ali, MPH, a consumer safety officer at the FDA. "We've had reports in which parts of the toothbrush broke off during use and were released into the mouth with great speed, causing broken teeth and presenting a choking hazard."
FDA regulates toothbrushes -- whether manual or electric -- as medical devices that are intended to help prevent tooth decay. Injuries reported from using the Spinbrush powered toothbrush include the following:
- Chipped or broken teeth
- Cuts to the mouth and gums
- Swallowing and choking on broken pieces
- Injuries to the face and eyes
The FDA has issued a warning to consumers that the battery-powered Arm & Hammer Spinbrush can break during use and cause serious injuries. Image courtesy of the FDA.
FDA is alerting the public about the potential for injury while using the following models of Spinbrush:
- Spinbrush ProClean
- Spinbrush ProClean Recharge
- Spinbrush Pro Whitening
- Spinbrush Sonic
- Spinbrush Sonic Recharge
- Spinbrush Swirl
- Spinbrush Classic Clean
- Spinbrush For Kids
- Spinbrush Replacement Heads
Company takes action
The Spinbrush handle contains batteries and a motor that operates the brushes, which are attached to a brush head. In the models of Spinbrush made for adults, the brush head is removable and can be replaced. But the brush head should not pop off during normal use, Ali noted.
The Spinbrush for Kids models, which have different handle designs, such as Spiderman and Thomas & Friends, do not have removable brush heads. Nonetheless, problems with the Spinbrush for Kids also have been reported, such as cut lips, burns from the batteries, and bristles falling off and lodging in a child's tonsils.
"FDA's concern is that the unexpected release of any part of this battery-powered toothbrush during use poses a risk of injury," said Steven Silverman, director of the Office of Compliance in FDA's Center for Devices and Radiological Health. "And the risk is higher in children or adults who may need assistance but are not supervised while using the toothbrush."
An FDA inspection last year of Church & Dwight, which manufactures the Spinbrush, uncovered evidence that numerous consumer complaints had not been reported to the agency. On May 16, 2011, the FDA warned the company of its violations of the Federal Food, Drug, and Cosmetic Act, including failure to report serious injuries within a reasonable time frame.
After further discussions with Church & Dwight about the risks of the battery-powered Spinbrush, the company has now taken some action, according to the FDA:
- Improved the labeling to caution consumers to change the brush head every three months or sooner if the brush is worn or parts are loose.
- Added bristles that change color with wear to give consumers a visual reminder of when to replace the brush head.
- Issued a safety notice about Spinbrush in TV and print ads; the safety notice also appears on the Spinbrush website and the interactive voice response to consumers who call the company's toll-free telephone numbers.
Copyright © 2012 DrBicuspid.com