{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T05:07:54Z","timestamp":1780117674117,"version":"3.54.0"},"reference-count":45,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T00:00:00Z","timestamp":1678233600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Lasers Surg Med"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and objectives<\/jats:title><jats:p>Home\u2010use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home\u2010use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home\u2010use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home\u2010use IPL treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>For this analysis of voluntary reports, we queried a distributor\u2032s postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e\u2010mail, company\u2010sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home\u2010use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home\u2010use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment\u2010adjusted reporting rate for AE cases (number of AE cases\/100,000 shipped IPL devices) was 67\/100,000 during this 6\u2010year period. The most commonly reported AEs were pain of skin 27.8% (470\/1692), \u201cthermal burn\u201d 18.7% (316\/1692), and erythema 16.0% (271\/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home\u2010use IPL treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This is the first such report documenting AEs for home\u2010use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home\u2010use low\u2010fluence IPL technology.<\/jats:p><\/jats:sec>","DOI":"10.1002\/lsm.23650","type":"journal-article","created":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T15:40:36Z","timestamp":1678290036000},"page":"414-422","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Assessment of adverse events for a home\u2010use intense pulsed light hair removal device using postmarketing surveillance"],"prefix":"10.1002","volume":"55","author":[{"given":"Anne M.","family":"Hattersley","sequence":"first","affiliation":[{"name":"Procter &amp; Gamble  Mason Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kiernan","sequence":"additional","affiliation":[{"name":"CyDen Ltd.  Swansea Wales UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Goldberg","sequence":"additional","affiliation":[{"name":"Skin Laser &amp; Surgery Specialists of NY and NJ  Hackensack New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Dierickx","sequence":"additional","affiliation":[{"name":"Skinperium Clinic  Luxembourg Luxembourg"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David H.","family":"Sliney","sequence":"additional","affiliation":[{"name":"Bloomberg School of Public Health Johns Hopkins University  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merete","family":"Haedersdal","sequence":"additional","affiliation":[{"name":"Copenhagen University Hospital Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6133-9639","authenticated-orcid":false,"given":"J. 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