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U.S. Department of Health and Human Services

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

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PREVENTICE TECHNOLOGIES INC. PREVENTICE BODYGUARDIAN HEART MONITOR Back to Search Results
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.

 
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Brand NamePREVENTICE BODYGUARDIAN HEART MONITOR
Type of DeviceBODYGUARDIAN
Manufacturer (Section D)
PREVENTICE TECHNOLOGIES INC.
MDR Report Key7665748
MDR Text Key113461076
Report NumberMW5078271
Device Sequence Number0
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 07/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device LOT NumberBASE # B91018
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: 07/05/2018 Patient Sequence Number: 1
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