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

Model Number 900-0634-00

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Skin Irritation (2076)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

Complaint handling evaluation: dhr review was performed by braemar manufacturing, llc quality assurance, with no contributing factors identified.Ifu provides warning indications for discontinuing use and contacting a medical practitioner or customer service in the event that severe skin irritation occurs.Patient indicated that they are allergic to adhesive and cannot wear any devices that have adhesives.Medical affairs.No additional information is known to braemar manufacturing, llc at this time.

Event Description

On 28-may-2019, braemar manufacturing, llc was made aware of patient allegation of burn/skin reaction.The patient wore a c6 patch monitor and contacted their healthcare professional due to an allegation of blisters and skin irritation.The patient indicated to their healthcare professional that the burn/skin irritation is very serious and that it is a third degree burn.The healthcare professional contacted their account executive contact and notified of the event, indicating that they do not believe that the skin irritation/burn is serious.Note: the become aware of the event for lifewatch services, inc.And braemar manufacturing is 28-may-2019, based on notification date by the initial reporter listed.

• Brand Name: MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
• Type of Device: MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 8739022
• MDR Text Key: 149526671
• Report Number: 2133409-2019-00006
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6S0
• UDI-Public: +B146C6S0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 900-0634-00
• Device Catalogue Number: 100-0046-02
• Was Device Available for Evaluation?: No
• Device Age: 1 YR
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR