MAUDE Adverse Event Report: LIFEWATCH SERVICES LIFEWATCH MCT 1 LEAD PATCH (MCT 1LP)

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Lead(s), Burn(s) From (3161)

Event Date 03/18/2018

Event Type  Injury  

Event Description

My dr ordered me to wear a heart monitor from a company called life watch.I was told if i was to experience any irritation to remove the device for a few hrs and then reapply.On (b)(6) 2018 the heart monitor began to beep while i was asleep, i woke up and it was hot.I removed the device and noticed that the area it was located was irritated with bumps and redness.After a few days i noticed that it was getting worst.I called the dr's office only to receive a voicemail three days later telling me i should've called the company that owns the monitor.I wasn't told to do that once the heart monitor was placed on me not did i sign any papers stating so.No one seems to care and due to this i have a permanent burn on my chest in the shape of heart monitor.I will never be able to wear tanks tops again and its depressing that no one seems to want to acknowledge or hold themselves accountable.I wanted to report this as i'm thinking about contacting a lawyer.I told the lady at the heart center that i was allergic to latex and she stated it was latex free, therefore if it's latex free or not i shouldn't have received a permanent burn.I was due to return the device on (b)(6) 2018 in order to keep from being charged (b)(6).However i did keep a piece of the outer part of the sticker part.

• Brand Name: LIFEWATCH MCT 1 LEAD PATCH (MCT 1LP)
• Type of Device: LIFEWATCH
• Manufacturer (Section D): LIFEWATCH SERVICES
• MDR Report Key: 7471924
• MDR Text Key: 107021991
• Report Number: MW5076832
• 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: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 110