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

Model Number SP1007-A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Reaction (2414); Skin Inflammation (2443)

Event Date 09/26/2017

Event Type  Injury  

Event 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
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PREVENTICE TECHNOLOGIES, INC.
• MDR Report Key: 6940262
• MDR Text Key: 89223862
• Report Number: MW5072680
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00852132007026
• UDI-Public: 00852132007026
• 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: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79