MAUDE Adverse Event Report: PREVENTICE SERVICES, LLC BODYGUARDIAN MINI EL; DETECTOR AND ALARM, ARRHYTHMIA

Lot Number B43396

Device Problems Labelling, Instructions for Use or Training Problem (1318); Patient-Device Incompatibility (2682)

Patient Problems Caustic/Chemical Burns (2549); Tissue Breakdown (2681); Blister (4537)

Event Date 01/23/2022

Event Type  Injury  

Event Description

I was wearing a heart monitor.The strip that had the leads on it had acrylic adhesive on it.It caused a chemical burn on my skin which led to blistering and scabbing.This could have been avoided or mitigated if the company had warned the consumer about it, but they did not, nor did they give any instructions on how to treat the possible adverse reaction.My doctor's office has confirmed that this device has previously caused this reaction in other patients.Fda safety report id# (b)(4).

• Brand Name: BODYGUARDIAN MINI EL
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PREVENTICE SERVICES, LLC
• MDR Report Key: 13385912
• MDR Text Key: 284712129
• Report Number: MW5107046
• 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: 01/25/2022

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 Expiration Date: 07/01/2023
• Device Lot Number: B43396
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Patient Sequence Number: 1
• Treatment: ADVAIR; ALLEGRA; BISOPROLOL; FAMOTIDINE; GUANFACINE; MELOXICAM ; MONTELUKAST; WELLBUTRIN ; ZYRTEC
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White