Device product
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Z-1103-2020
Product summary
- Firm
- Fridababy LLC
- Event
- Event 84707
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 480,144
- Official record key
device-enforcement:Z-1103-2020
Official wording
Reason: FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
Code information: All Lots
Distribution pattern: Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.
Derived failure modes
-
Foreign material or chemical contamination
metal piece