MAUDE Adverse Event Report: 3M 3M RED DOT ELECTRODES; EKG ELECTRODES

Model Number V2228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 01/22/2017

Event Type  Injury  

Event Description

Patient has burns that he states were caused by and found after mri scans and were caused by ekg electrodes.No leads or devices were attached to the electrodes.

• Brand Name: 3M RED DOT ELECTRODES
• Type of Device: EKG ELECTRODES
• Manufacturer (Section D): 3M
• MDR Report Key: 6275787
• MDR Text Key: 65862973
• Report Number: MW5067441
• Device Sequence Number: 1
• Product Code: DRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V2228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 86