MAUDE Adverse Event Report: BIOTEL / BRAEMAR MANUFACTURING, LLC MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 220-0545-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 03/26/2021

Event Type  Injury  

Event Description

The device malfunctioned and i called the company to resolve, i also told them that the adhesive was irritating me and i would not be continuing use of the monitor and sending device i also said that turn on the monitor i will do so but will not put the device on my chest my chest site is red, sore, itchy and has red bumps.Fda safety report id# (b)(4).

• Brand Name: MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BIOTEL / BRAEMAR MANUFACTURING, LLC
• MDR Report Key: 11607853
• MDR Text Key: 243768913
• Report Number: MW5100509
• Device Sequence Number: 1
• Product Code: DSI
• 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: 03/30/2021

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: No Information
• Device Model Number: 220-0545-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 68