MAUDE Adverse Event Report: 3M COMPANY 3M RED DOT; ELECTRODE, ELECTROCARDIOGRAPH

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

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 03/10/2021

Event Type  Injury  

Event Description

Itching, severe irritation, blistering and burning of skin.Fda safety report id# (b)(4).

• Brand Name: 3M RED DOT
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 11506725
• MDR Text Key: 240690738
• Report Number: MW5100047
• 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: Patient
• Type of Report: Initial
• Report Date: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 138