MAUDE Adverse Event Report: EKG ELECTRODE; ELECTRODE, ELECTROCARDIOGRAPH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Type  No Answer Provided  

Event Description

Mri thermal burn to right chest.Fda safety report id# (b)(4).

• Brand Name: EKG ELECTRODE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• MDR Report Key: 11862417
• MDR Text Key: 252297379
• Report Number: MW5101482
• Device Sequence Number: 1
• Product Code: DRX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/19/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 103