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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)

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BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) Back to Search Results
Model Number 900-0634-00
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Burn, Thermal (2530)
Event Type  Injury  
Manufacturer Narrative

Braemar manufacturing is no longer investigating this incident and considers this matter closed.

 
Event Description

On (b)(6) 2019, braemar manufacturing, llc was made aware of patient allegation of burn/skin reaction. The patient allegedly wore a c6 patch monitor in event mode and indicated that her skin reacted adversely to the monitor and that she experienced a skin burn. The patient indicated that she did not experience an adverse event when she wore the first patch and that the event occurred during the second week of use.

 
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Brand NameMOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
Type of DeviceMOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan MN 55121
MDR Report Key8876010
MDR Text Key153801858
Report Number2133409-2019-00001
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 08/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number900-0634-00
Device Catalogue Number900-0634-00
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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