Indoor tanning injuries: an evaluation of FDA adverse event reporting data

Background/Aims: In 1979 the Food and Drug Administration (FDA) designated indoor tanning units would be regulated medical devices and that each must have an exposure timer. In 1985 FDA added a scheduled series of doses designed to allow tanning with little risk of concomitant sunburn. Subsequently FDA/CDRH maintained databases in which medical device associated injuries were reported. The databases, MAUDE and its predecessor MDR, are available online. While these records, in part, are not intended for evaluation of adverse event rates, analysis provides insight into the etiology of UV‐related tanning injuries. Methods/Results: We compiled 142 records reported for 1985‐2006 including 22% noninjury malfunctions. Of the reported injuries ∼50% resulted from UV exposure, an average of