N/A DGP-PM2Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15060441917611), received between Dec 8, 2021 and Aug 7, 2024 — 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.

• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A GROUNDING PAD BURN.

  Patient problems: Burn(s)

  MAUDE report 19935360 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED ON THE LEFT POSTERIOR THIGH DURING A LUMBAR RADIOFREQUENCY ABLATION PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 19726319 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY (RF) ABLATION PROCEDURE, THE PATIENT EXPERIENCED FIRST TO SECOND DEGREE BURNS ON THE RIGHT UPPER THIGH.

  Patient problems: Burn(s)

  MAUDE report 18769301 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN FROM THE GROUNDING PADS.

  Patient problems: Burn(s)

  MAUDE report 16088569 ↗
• InjuryDec 30, 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 FROM THE GROUNDING PAD. THE GROUNDING PAD WAS DISCARDED.

  Patient problems: Burn(s)

  MAUDE report 16080819 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BURN FROM THE GROUNDING PADS DURING A GENICULAR RF PROCEDURE. IT WAS NOTED THAT THE BURN WAS FIRST DEGREE OUTER EDGES AND SECOND DEGREE WITH YELLOW SLOUGH IN THE CENTER. THE PATIENT WAS BROUGHT TO EMERGENCY ROOM TO TREAT THE BURN. THE PATIENT WAS DISCHARGED AND WAS PRESCRIBED SILVADENE DRESSING TREATMENTS.

  Patient problems: Burn(s)

  MAUDE report 15571352 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN UNDER THE GROUNDING PAD ON THE RIGHT LATERAL FLANK AFTER THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE GROUNDING PAD WAS PLACED ON AN AREA WITH NO HAIR AND IT WAS UNCLEAR IF THE PATIENT HAD LOTION ON THE SKIN. THE PATIENT WAS REFERRED TO WOUND CARE.

  Patient problems: Burn(s)

  MAUDE report 15225962 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED BURNS UNDER THE RIGHT CALF FROM THE GROUNDING PAD. UPON CLOSER INSPECTION, EXCESS HAIR WAS NOTED ON THE PATIENTS RIGHT CALF WHICH MAY HAVE INTERFERED WITH THE PAD ADHERING SECURELY TO THE SKIN. IT WAS NOTED THAT THERE WERE NO PRIOR SKIN INJURIES WHERE THE GROUNDING PAD WAS PLACED AND THERE WERE NO OBVIOUS CREASES OR AIR BUBBLES WHEN THE GROUNDING PAD WAS APPLIED. THE GROUNDING PAD WAS DISCARDED.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 14296675 ↗
• InjuryMar 8, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT HAD A BURN FROM THE GROUNDING PAD WHICH WAS PLACED ON THE LEFT POSTERIOR THIGH. IT WAS NOTED THAT THERE WERE HAIRS PRESENT AT THE PATIENTS POSTERIOR THIGH.

  Patient problems: Burn(s)

  MAUDE report 13692588 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELECTRICAL BURN WITH THE GROUNDING PAD. PRIOR TO USE, THE GROUNDING PAD WAS STORED IN THE ROOM WITH A TEMPERATURE OF 62 TO 70 DEGREES FAHRENHEIT. DURING THE PROCEDURE THE GROUNDING PAD WAS PRESSED FLAT AGAINST THE PATIENTS THIGH AND WHEN IT WAS REMOVED, THE AREA UNDERNEATH WAS NOTICED TO BE RED WITH 1.5CM BLANCHED AREA. THE AREA WAS MILDLY WARM TO TOUCH BUT NOT PAINFUL. THE PATIENT WAS PROVIDED WITH SILVADENE CREAM TO APPLY TO THE BURN. DURING THE POSTOP FOLLOW UP, THE PATIENT REPORTED THAT THE AREA HAD SCABBED OVER WITH NO SIGNS OF INFECTION. THE DEVICE WAS NOT RETURNED PER HOSPITAL POLICY.

  Patient problems: Burn(s)

  MAUDE report 12961585 ↗