MAUDE Adverse Event Report: CONMED CORPORATION SOFTRACE; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2310-003

Patient Problems Hemorrhage/Bleeding (1888); Partial thickness (Second Degree) Burn (2694)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

On assessment this morning, ekg lead on the right upper inside of the arm had burned the skin where it had been placed.The gel that was underneath the lead was swollen, and falling off.The burn had taken off the first layer of skin, and the arm was bleeding.Manufacturer response for electrode, electrocardiograph, softrace (per site reporter).Only response has been follow-up questions to help them in their investigation.

• Brand Name: SOFTRACE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 18855172
• MDR Text Key: 337090250
• Report Number: 18855172
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2310-003
• Device Catalogue Number: 2310-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 DA
• Patient Sex: Female