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U.S. Department of Health and Human Services

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

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NISSHA FIS, INC VERMED ECG MONITORING ELECTRODES ELECTRODE ELECTROCARDIOGRAPH Back to Search Results
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.

 
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Brand NameVERMED ECG MONITORING ELECTRODES
Type of DeviceELECTRODE ELECTROCARDIOGRAPH
Manufacturer (Section D)
NISSHA FIS, INC
1051 perimeter dr
ste 600
schaumburg IL 60173
MDR Report Key7780311
MDR Text Key117255775
Report NumberMW5079121
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device LOT Number50117V13
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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