MAUDE Adverse Event Report: NISSHA FIS, INC VERMED ECG MONITORING ELECTRODES; ELECTRODE ELECTROCARDIOGRAPH

Lot Number 50117V13

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/22/2018

Event Type  Injury  

Event Description

I was wearing a 30 day heart monitor and the leads made large burns on my skin.

• Brand Name: VERMED ECG MONITORING ELECTRODES
• Type of Device: ELECTRODE ELECTROCARDIOGRAPH
• Manufacturer (Section D): NISSHA FIS, INC ; 1051 perimeter dr ; ste 600; schaumburg IL 60173
• MDR Report Key: 7780311
• MDR Text Key: 117255775
• Report Number: MW5079121
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 50117V13
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 98