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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PREVENTICE SERVICES, LLC BODYGUARDIAN HEART DETECTOR AND ALARM, ARRYTHMIA

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PREVENTICE SERVICES, LLC BODYGUARDIAN HEART DETECTOR AND ALARM, ARRYTHMIA Back to Search Results
Model Number REF BC1002-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Skin Inflammation (2443)
Event Date 08/08/2019
Event Type  Injury  
Event Description

Was prescribed heart monitor for a month 24/7. Given preventice bodyguardian heart monitor. Need to attach electrodes to the same spot all the time. Cannot do it any more. It's inflamed, bleeding, infected wounds. Cannot use monitor at nights, too heavy and bulky, losing contacts constantly. Wasted 30 days of valuable time. This monitor should never be on a market. Skin inflammation. Fda safety report id# (b)(4).

 
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Brand NameBODYGUARDIAN HEART
Type of DeviceDETECTOR AND ALARM, ARRYTHMIA
Manufacturer (Section D)
PREVENTICE SERVICES, LLC
MDR Report Key8888456
MDR Text Key154311492
Report NumberMW5088972
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 08/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberREF BC1002-A
Was Device Available For Evaluation? No
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: 08/12/2019 Patient Sequence Number: 1
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