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U.S. Department of Health and Human Services

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

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BIOTEL / BRAEMAR MANUFACTURING, LLC MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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).

 
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Brand NameMCOT MOBILE CARDIAC OUTPATIENT TELEMETRY
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
BIOTEL / BRAEMAR MANUFACTURING, LLC
MDR Report Key11607853
MDR Text Key243768913
Report NumberMW5100509
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received04/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number220-0545-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/01/2021 Patient Sequence Number: 1
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