Skintact RS25A30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531593241), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN ELECTROSURGICAL PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL SKINTACT RS25A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT CLAIMED THAT THE "PRODUCT CAUSE IRRITATION IN A PATIENT WHEN PRACTICE THE PROCEDURE". IT IS UNCLEAR WHETHER THE IRRITATION WERE LOCATED UNDERNEATH THE ELECTRODE RESPECTIVELY UNDERNEATH THE GEL OR THE SURROUNDING FOAM ARE AND OF WHAT SEVERITY THE IRRITATION WAS. NO INFORMATION ABOUT THE NATURE OF THE PROCEDURE, THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENT, HOW THE SKIN WAS PREPARED AND IF AND HOW THE INJURY WAS TREATED HAVE BEEN DISCLOSED TO US DESPITE OF REPEATED REQUESTS.

  Patient problems: Skin Irritation

  MAUDE report 7697569 ↗