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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIONET, INC. CARDIONET AMBULATORY ECG MONITOR

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CARDIONET, INC. CARDIONET AMBULATORY ECG MONITOR Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091); Burn, Thermal (2530)
Event Date 02/03/2018
Event Type  Injury  
Event Description

I was recently prescribed a 72 monitor with cardiokey by my cardiologist, dr. (b)(6). I received the cardiokey (b)(6) 2018 and began wearing it (b)(6) 2018. I wore the first set of patches beginning the morning of (b)(6) 2018, and changed them on the evening of (b)(6) 2018. When i removed them on the morning of (b)(6) 2018, the patches had burned my skin. I had itchy, painful, blistered welts where the electrode patches were placed.

 
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Brand NameCARDIONET
Type of DeviceAMBULATORY ECG MONITOR
Manufacturer (Section D)
CARDIONET, INC.
MDR Report Key7247504
MDR Text Key99346659
Report NumberMW5075105
Device Sequence Number1
Product Code DSI
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 02/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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

Patient TREATMENT DATA
Date Received: 02/06/2018 Patient Sequence Number: 1
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