SOFTRACE 2310-003Recalls & reported problems
Conmed Corporation · SOFTRACE LIMB BAND, NEONATAL/PEDIATRIC ECG ELECTRODE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405038973), received between Mar 11, 2024 and Mar 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 2310-003, ECG SOFTRACE LIMB BAND CS DEVICE WAS BEING USED ON A PATIENT ON 14FEB24, AND ¿PATIENT HAS A WOUND ON THE ABDOMEN CAUSED BY LIMB LEAD ELECTRODES. WOUND TEAM WAS CONSULTED AND TREATED THE PATIENT. THE WOUND REQUIRED THE PATIENT RECEIVE EXTRA TREATMENT AND INCREASED MONITORING.¿ PER FOLLOW-UP ASSESSMENT, "DOCUMENTATION FROM THE WOUND TEAM EVALUATION DESCRIBES IT AS 'SIGNIFICANT FINDING OF ABRASION FOUND ON RIGHT LOWER QUADRANT ABDOMEN'¿, AND THE REPORTED INJURY WAS "NOT A BURN". THE "EXTRA TREATMENT" WAS DESCRIBED AS "CLEANED WITH SALINE APPLIED MEDIHONEY GEL AND COVERED IS SILICONE BORDERED FOAM. ORDERED TO CHANGE DRESSING EVERY 48HRS". THE ELECTRODES WERE PLACED ON THE ARMS AND ONE ON THE RIGHT ABDOMEN. PREVIOUSLY, LEADS HAD BEEN PLACED ON THE CHEST AND ABDOMEN; IT WAS UNKNOWN IF THEY HAVE BEEN PREVIOUSLY PLACED IN THE EXACT LOCATION OF THE ABRASION. THERE WAS NO SIGN OF SKIN IRRITATION PRIOR TO APPLICATION, NO LEFTOVER GEL FROM PREVIOUS APPLICATION OF THE DEVICE. THERE WAS NO DIFFICULTY IN REMOVING THE ELECTRODES, WHICH WERE NOTED AS "LOSING THEIR STICK". UPON REMOVAL, THERE WAS NO APPARENT DEFECT NOTICED OF
Patient problems: Abrasion
MAUDE report 18877155 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.