NEOTRODE 1741-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30653405004336), received between Dec 26, 2023 and Dec 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 1741-003, ECG NEONATAL II,3 WIRE,TP,ADGEL WAS BEING USED AND ¿(B)(6) 2023: AN INJURY WAS CAUSED BY THE REMOVAL OF THE ELECTRODE DURING THE NEWBORN'S BATH, DESCRIBED VISUALLY AS A BURN. EXAT DATE IS UNKNOWN.¿. FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO INFORMATION HAS BEEN OBTAINED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 18391753 ↗
• InjuryDec 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE: PER FURTHER ASSESSMENT RECEIVED ON (B)(6) 2024 CLARIFICATION REGARDING (24 WEEKS 1/7) WAS "THE BABY WAS 24 WEEKS + 1 DAY". IT WAS ALSO FOUND THAT "THE NURSE DOCUMENTED A BLACK SORE AT THE ELECTRODE SITE. IN THE NOTES, IT IS DOCUMENTED THAT THIS NEWBORN HAD SEVERAL BRUISES IN OTHER AREAS OF HIS BODY." IT WAS NOT SPECIFIED IN THE FILE, "BUT IT IS STANDARD PROCEDURE TO DRY THE SKIN BEFORE INSTALLING THE ELECTRODES." IT WAS NOT IN THE FILE IF THE ELECTRODE WAS DIFFICULT TO REMOVE. IT IS UNKNOWN IF MEDICAL SURGICAL/INTERVENTION WAS NEEDED AS "THE PATIENT WAS TRANSFERRED TO ANOTHER CENTER (NOT RELATED TO THE ELECTRODE INJURY). SO, WE DON'T HAVE MUCH INFORMATION ABOUT THE NEWBORN." THERE WAS AN EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT; HOWEVER, "NOT RELATED TO ELECTRODE WOUND". THE ELECTRODE WORKED WELL DURING THE PROCEDURE. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 1741-003, ECG NEONATALII,3 WIRE, TP, ADGEL WAS BEING USED ON (B)(6) 2023 AND ¿WE NOTICED A WOUND IN A VERY LARGE PREMATURE BABY (24 WEEKS 1/7). THE INJURY WAS DESCRIBED AS A BLACKENED WOUND AT THE ELECTRODE SITE ON THE LEFT.¿. FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO INFORMA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18391750 ↗