FemTouch™Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109142128), received between Apr 13, 2019 and Oct 16, 2019 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY CONTACTED LUMENIS ABOUT AN 'ADVERSE EVENT' THAT MAY HAVE OCCURRED WHILE AN ACUPULSE CO2 LASER WAS BEING UTILIZED. THE REPORTER OF THIS EVENT WAS "CALLING ON BEHALF OF THE DOCTOR WHO THOUGHT THERE MIGHT HAVE BEEN AN ADVERSE EVENT. THE CASE WAS MARKED AS 'SAFETY' AS THE DR WAS UNSURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9196747 ↗
• InjuryApr 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE VAGINAL TREATMENT WAS FOR STRESS INCONTINENCE OF THE BLADDER WITH THE FEMTOUCH SN (B)(4) AND HP SN (B)(4). AFTER HAVING A VAGINAL DISCHARGE FOR SOME 10 DAYS, PATIENT WAS TREATED FOR YEAST INFECTION AND FELT FINE FOR SIX WEEKS. THEREAFTER, THE PATIENT SUFFERED RENEWED SYMPTOMS FOLLOWED BY A SERIOUS INFECTION RESULTING IN HOSPITALIZATION FOR 5 DAYS WITH SEPSIS.

  Patient problems: Sepsis

  MAUDE report 8512500 ↗