The cross-sectional study, published in The BMJ, examined more than 4.4 million reports between September 2019 and December 2022 and found that 13.6% of them were filed late, with over two-thirds submitted more than six months after manufacturers became aware of adverse events.
Of the reports included in the study, 13,587 involved deaths, 1.55 million involved injuries and 2.87 million documented device malfunctions. Among these, 197,606 reports were submitted between 31 and 180 days after notification, while 402,891 were delayed beyond 180 days.
An additional 15.5% of reports had missing or invalid date data, making it unclear whether they had met the reporting deadline. The study also found that late reporting was highly concentrated among a small number of manufacturers. Three device companies accounted for 54.8% of late reports, with certain medical devices, such as infusion pumps and continuous glucose monitors, having particularly high rates of late reports.
