CHATTANOOGA 2763Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912293013), received between Jun 22, 2020 and Feb 6, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A BURN DURING TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 24285047 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUSTAINED 2ND DEGREE BURNS UNDER 3 ELECTRODES DURING TREATMENT THAT REQUIRED MEDICAL TREATMENT AT URGENT CARE.

  Patient problems: Burn(s)

  MAUDE report 21915074 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE CLINICIAN REPORTED A SMALL BURN ON THE PATIENT AFTER WHICH THIS UNIT WAS PROMPTLY REMOVED FROM SERVICE.

  Patient problems: Burn(s)

  MAUDE report 21370553 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE UNIT HAS GIVEN ELECTRICAL BURNS TO PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 21317570 ↗
• InjuryMar 18, 2022Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE UNIT APPLICATOR ALLEGEDLY BURNED THE PATIENT ON THE NECK AREA. THE BIOMED CLAIMS PER STATEMENTS OF CLINICAL STAFF THIS MIGHT HAVE BEEN A USER ERROR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13805737 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS BURNED ON THE LATERAL COMPONENT OF THE RIGHT KNEE DISTAL TO THE JOINT LINE WHILE ON IFC. THE INTENSITY LEVEL OF THE TREATMENT WAS NOT DOCUMENTED WITHIN THE REPORTER'S NOTES, BUT THE PATIENT HAD INDICATED THAT THE STIMULATION WAS "STRONG BUT COMFORTABLE." IT WAS REPORTED THAT THE REPORTER WAS NOT SURE WHICH ELECTRODE PADS WERE USED FOR THIS TREATMENT, BUT THEY WERE A SIZE 2 X 2. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Lead(s), Burn(s) From

  MAUDE report 10178685 ↗