FDAnews Device Daily Bulletin

Failure to report adverse events from a battery-operated toothbrush were among several observations in a Form 483 generated after a Jan. 9 to Feb. 13 inspection of Church & Dwight’s Princeton, N.J., facility. The company’s Spinbrush model was the subject of multiple customer complaints, including reports of batteries exploding; corrosive liquid leaking from the battery compartment and burning skin or mouth tissue; and the handle heating enough to burn. However, the company did not submit MDR reports within 30 days of hearing about these incidents, the Form 483 states.
The GMP Letter