Multiple reports to the Food and Drug Administration revealed a major problem with Arm & Hammer Spinbrush electric toothbrushes (called Crest Spinbrush prior to 2009). The reports indicate the toothbrush breaks apart when the bristles run at fast speed in the mouth during brushing resulting in broken teeth, cuts to the mouth and gums, parts flying into the face or creating a potential to block a person’s airway. Oral hygiene devices (electronic or manual) fall under FDA authority as medical devices to prevent tooth decay and periodontal disease.
The FDA uncovered the problems in May 2011 during inspection of the manufacturer of the battery powered Spinbrush, Church & Dwight Co., but release to the public occurred on Feb. 17. The company disregarded the Federal Food, Drug and Cosmetic Act by neglecting to report severe injuries. Any injury from a medical device reported to the company manufacturing a product in question must report each event to the FDA within a reasonable timeframe. The FDA required the company to generate labeling changes and to educate the public with television and print ads from this product.
Within the last two years, Church & Dwight Co. Inc. produced eight different models and sold 40 million devices of the Arm & Hammer Spinbrush that could cause injury. FDA advises consumers to check there home for ownership of any of the following models.
* Spinbrush ProClean
* Spinbrush ProClean Recharge
* Spinbrush Pro Whitening
* Spinbrush SONIC
* Spinbrush SONIC Recharge
* Spinbrush Swirl
* Spinbrush Classic Clean
* Spinbrush For Kids
* Spinbrush Replacement Heads
Church & Dwight Co. Inc posted on their website directions for consumers to obtain facts for safe use of the Spinbrush toothbrushes. Below describes the steps to follow for safe utilization of the device.
First, consumers need to inspect the brush head on the device for loose parts before each use and check the brush head for tight connection to the handle. Extended use, worn or loose parts can lead to breakage, generation of flying small parts and potential for risk of chocking. If any damaged or loose bristles appear, do not use the brush. Report the issue to Church & Dwight Co. Inc. by phoning toll free at 1-800-352-3384 or 1-800-561-0752.
Second, consumers need to replace the bristle section or brush head every three months of active use or sooner if damaged is evident. Proper maintenance usually prevents unsafe conditions.
Third, the FDA advises parents of younger children or significant others taking care of adults who require assistance to supervise these individuals with inspection of the Spinbrush devices. Further, caregivers of children or dependent adults need to supervise the dependent love ones’ ability to conduct proper brushing and avoiding biting down on the brush head.
The FDA maintains their MedWatch Program for consumers to reporting any potential or actual problem with any medications or medical devices using this link at FDA Form 3500. This valuable resource to the public allows easy reporting of serious events.