N/A DGP-PMC2Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15060441917635), received between Feb 9, 2022 and Sep 4, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE ACCOUNT REACHED OUT TO LET REP KNOW THAT THEY HAD AN RF BURN ON A PATIENT ON (B)(6) 2025. THE PATIENT WAS A MALE AND WAS NOT SHAVED WHERE THE GROUNDING PAD WAS PLACED. PATIENT WAS PRESCRIBED SILVADINE TO HELP WITH BURN.

  Patient problems: Burn(s)

  MAUDE report 22961926 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED GROUNDING PAD BURNS THAT REQUIRED FURTHER MEDICAL INTERVENTION

  Patient problems: Burn(s)

  MAUDE report 20246839 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT HAD AN RFA ON 8/5 AND REPORTED A BURN ON THE BACK OF THEIR RIGHT THIGH. BURN CREAM WAS PRESCRIBED TO AID IN HEALING.

  Patient problems: Burn(s)

  MAUDE report 20200620 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED GROUNDING PAD BURNS THAT REQUIRED FURTHER MEDICAL INTERVENTION.

  Patient problems: Burn(s)

  MAUDE report 20157828 ↗
• InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SECOND DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 19686569 ↗
• InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SECOND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19686568 ↗
• InjuryJul 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SECOND DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 19686565 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN.

  Patient problems: Burn(s)

  MAUDE report 19653066 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN AND A BLISTER WAS NOTICED WHEN GROUNDING PAD REMOVED POST RADIOFREQUENCY ABLATION PROCEDURE. THE PATIENT WAS GIVEN SILVER SULFADIAZINE OINTMENT AND WAS HEALING WELL.

  Patient problems: Burn(s)

  MAUDE report 15712681 ↗
• InjuryFeb 9, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT THAT HAD BURN MARKS WHERE THE PAD WAS PLACED.

  Patient problems: Burn(s)

  MAUDE report 13494944 ↗