On February 16, 2012, the Food and Drug Administration issued a
consumer update regarding the Spinbrush®, a battery operated toothbrush available for adults and children. According to the update, certain models and makes cause injuries during brushing.
Both Crest® and Arm & Hammer® sell the Spinbrush which comes in a number of models and is manufactured by Church & Dwight Co., Inc. These include the Spinbrush ProClean; Spinbrush ProClean Recharge; Spinbrush Pro Whitening; Spinbrush SONIC; Spinbrush SONIC Recharge; Spinbrush Swirl; Spinbrush Classic Clean, and Spinbrush for Kids.
The FDA received numerous reports stating that the Spinbrush causes serious injuries to children and adults. The Spinbrush for adults has a removable head which, if broken or loose, with great speed may fly into the mouth causing chipped teeth, broken teeth, and even poses a choking hazard. Bruises and scars to the mouth and gums along with face injuries are other reported incidents from adults.
Spinbrush for Kids does not have a removable head yet it also causes injuries to children including cut lips, burns from the batteries, and loose bristles lodging into the child’s tonsils.
In May of 2011, the FDA sent a warning to Church & Dwight Co., Inc. The company responded by the following actions:
- Adding bristles which change color to remind consumers to replace the removable head (which should be replaced once every three months
- Issued warnings through television and print media
- Improved warning labels to include the dangerous hazards of using the Spinbrush for longer periods than recommended
The FDA recommends that anyone with a damaged Spinbrush report it to Church & Dwight by calling 1-800-352-3384 or 1-800-561-0752. The agency also asks that anyone injured by the Spinbrush contact their
Safety Information & Adverse Event Reporting Program.
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Abbott lands a PMA win for its Absolute Pro stent, expanding its indication to treat patients with narrowing of the iliac arteries.
Abbott (NYSE:
ABT won expanded pre-market approval from the FDA for its Absolute Pro self-expanding stent system, according to an agency release.
The next-generation device, delivered via catheter, is now additionally indicated for use in narrowed iliac arteries.
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