Skintact RO21 /5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531591520), received between Dec 17, 2024 and Dec 17, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT (B)(6) UK. A MONITORING DISPERSIVE ELECTRODE [SPLIT ELECTROSURGICAL NEUTRAL ELECTRODE] SKINTACT MODEL RO21/5 AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT'S ABDOMEN AND AN EYE SURGERY WAS PERFORMED. THE INITIAL REPORT STATES "I WOULD LIKE TO RAISE MY CONCERN OVER THE NEUTRAL ELECTRODE PADS WHICH WE USE DURING THE MINOR LIST PROCEDURES WHEN WE USE SAFE AIR. ONE OF OUR PATIENTS HAS DEVELOPED SOME BLISTERS DUE TO THE NEURAL ELECTRODE PAD WHICH WE HAVE USED IN THE SURGERY." ADDITIONALY TO THE INITIAL COMPLAINT WE RECEIVED A PICTURE NOT SUITABLE TO SPECIFY THE LOCATION ON THE PATIENT BODY. HOWEVER TWO SMALL BLISTERS CAN BE SEEN. A SECOND PICTURE IS SHOWING A 2 PENCE COIN AND A PIECE OF PLASTIC WHICH IS A RESIDUE FROM THE LIFTING AID. THE TWO PICTURES HAVE BEEN COMMENTED BY THE INITIAL REPORTER "PHOTOS OF BLISTERS AND PLASTIC DRESSING WHICH WAS STUCK OVER THE LEFT HAND BLISTER (WHICH IS ON THE RIGHT AS YOU SEE THE PICTURE ). THE BIGGER BLISTER ( ON THE LEFT AS YOU SEE IT) LOOKS THE WORST. I HAVE PUT A TWO PENCE PIECE NEXT TO THE PIECE OF PLASTIC TO SHO

  Patient problems: Burn(s); Skin Inflammation/ Irritation

  MAUDE report 20949397 ↗