METRON 566583Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885914070755), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.

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

• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE FIRST REPORT OF AN ISSUE WITH TNS METRON ELECTRODE 2" SQUARE WAS REPORTED, HOWEVER VERY LITTLE INFORMATION WAS GIVEN. ON (B)(6) 2021, IT WAS REPORTED TO (B)(6) CUSTOMER SERVICE BY (B)(6) THAT "THERE WAS NO SERIOUS INJURY OR DEATH. THIS WAS A MINOR INJURY THAT NEEDED MINOR TREATMENT. THEY PUT A BANDAGE OVER THE WOUND. THE PATIENT DID NOT SEE A DR ONLY A PHYSICAL THERAPIST. THIS PHYSICAL THERAPIST WAS A TRAVELING THERAPIST WHO HAS ALREADY LEFT THE FACILITY. THE CUSTOMER NOTED SHE CAN REACH OUT IF MORE INFORMATION IN NEEDED FROM THAT PHYSICAL TRAINER. THE TYPE OF TREATMENT THAT WAS BEING USED WAS INTERFERENTIAL. (B)(6) STATED THE IFU FOR PRODUCT IS ASSUMED TO HAVE BEEN USED. THE INTENSITY WAS AT 61 WITH THE LENGTH OF TIME OF 15 MINUTES. THERAPIST CAN TREAT UNDER SCOPE OF PRACTICE NOT BY ORDER. THE PATIENT DID DISCONTINUED USE OF THIS PRODUCT. THE EQUIPMENT WAS TAKEN OUT OF SERVICE AS WELL. PATIENT MENTIONED INJURY A DAY LATER, WAS NOT INITIALLY APPARENT. THE WOUND WAS IN THE GENERAL AREA OF WHERE THE EQUIPMENT WAS USED." WITH THIS ORIGINAL INFORMATION IT WAS DETERMINED THAT THE EVENT WAS NOT REPORTABLE AT THIS TIME DUE NO SERIOUS INJURY OR DEATH. HOWEVER ON (B)(6)

  Patient problems: Burn(s)

  MAUDE report 13399329 ↗