MAUDE Adverse Event Report: PREVENTICE TECHNOLOGIES, INC. BODYGUARDIAN STRIP; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	SP1007-A
Health Effect - Clinical Codes	Reaction (2414); Skin Inflammation (2443)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Applied the bodyguardian strip (strip - silicone 1007) for cardiac heart monitor vertically to left of sternum.Next day, i had large welts where the 4 metal snaps were resting against my skin.I suspect these snaps are made of nickel which i had a reaction to this metal some 30 years ago.I tried to apply it the next day in the horizontal in an area not affected the first day and the same thing happened after 24 hours at the new location.

• Brand Name: BODYGUARDIAN STRIP
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PREVENTICE TECHNOLOGIES, INC.
• MDR Report Key: 6940262
• Report Number: MW5072680
• Device Sequence Number: 807719
• Product Code: DSI
• UDI-Device Identifier: 00852132007026
• UDI-Public: 00852132007026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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?: No
• Operator of Device: No Information
• Device Expiration Date: 07/04/2019
• Device Model Number: SP1007-A
• Device Catalogue Number: SP1007-A
• Device Lot Number: B34095
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 79