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

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).

• Brand Name: BODYGUARDIAN HEART
• Type of Device: DETECTOR AND ALARM, ARRYTHMIA
• Manufacturer (Section D): PREVENTICE SERVICES, LLC
• MDR Report Key: 8888456
• MDR Text Key: 154311492
• Report Number: MW5088972
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REF BC1002-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 68