Thermal products dominate FDA adverse-event reports for electrophysical agents

Introduction Electrophysical agents contribute to rehabilitation and symptom management through different forms of energy. Postmarket evaluation therefore requires device-specific interpretation of reported health effects and technical problems. Methods This retrospective descriptive study examined how technology, product-line concentration and reporting patterns shaped FDA device reports received during 2016–2025. Thirty-one product categories were searched. Device identity and application were screened, coded health effects and device problems were classified using exact-term dictionaries, and their co-occurrence was summarized by report. Results The main analysis included 4,934 reports. Passive thermal packs and powered heating pads contributed 83.0% of the cohort. ThermaCare alone accounted for 1,705 reports (34.6%) across multiple manufacturer labels. Cutaneous codes occurred in 2,786 reports (56.5%); cutaneous and use/instruction codes co-occurred in 737. Excluding the two dominant thermal families left 840 reports, with cutaneous codes in 44.8% and neurological or neuromuscular codes in 7.9%. Electrical stimulation, optical therapy and iontophoresis showed distinct profiles. Receipt-year distributions revealed product-specific clusters, while narrative examination identified mismatches between product category and the reported operating mode. The 11 death-coded reports were characterized by the reported circumstances and attribution. Discussion These findings support surveillance organized around identifiable product lines, actual operating modes and linked clinical–device information. Such reporting can guide targeted investigation and revision of device instructions and risk controls alongside continuing evaluation of therapeutic benefit.