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

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.

• Brand Name: CARDIONET
• Type of Device: AMBULATORY ECG MONITOR
• Manufacturer (Section D): CARDIONET, INC.
• MDR Report Key: 7247504
• MDR Text Key: 99346659
• Report Number: MW5075105
• Device Sequence Number: 1
• Product Code: DSI
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 60