MAUDE Adverse Event Report: PREVENTICE TECHNOLOGIES INC. PREVENTICE BODYGUARDIAN HEART MONITOR

Lot Number BASE # B91018

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Scar Tissue (2060); Burn, Thermal (2530)

Event Date 06/20/2018

Event Type  Injury  

Event Description

I was in severe pain and received severe burns under the electrode pads provided to me by (b)(4) while wearing the (b)(4) bodyguardian heart monitor.I wore the device from (b)(6) 2018 as prescribed by my cardiologist.I contacted the company and told them about the burns.They told me that they could send me other pads if i wanted them to continue on with my study.I informed them that their product should not injure a pt (obviously).Their response was "yeah".I refused the new pads and removed the monitor permanently.I reported the incident to my cardiologist as well.The skin that was burned scabbed over and i now have what looks to be a permanent scar in the center of my chest.Photos are available upon request.

• Brand Name: PREVENTICE BODYGUARDIAN HEART MONITOR
• Type of Device: BODYGUARDIAN
• Manufacturer (Section D): PREVENTICE TECHNOLOGIES INC.
• MDR Report Key: 7665748
• MDR Text Key: 113461076
• Report Number: MW5078271
• Device Sequence Number: 0
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: BASE # B91018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 77