MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT); C6 SENSOR

Model Number 900-0634-00

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to (b)(4) for evaluation on 05/16/19.The device evaluation is on-going at this time.

Event Description

On (b)(6) 2019, the initial reporter (distributor agent) notified (b)(4) of a patient allegation of burn/skin reaction.The patient was wearing a c6 unit and indicated burn marks on the skin where the electrodes were attached.

• Brand Name: MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)
• Type of Device: C6 SENSOR
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING; 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: 8617622
• MDR Text Key: 145352599
• Report Number: 2133409-2019-00003
• Device Sequence Number: 1
• Product Code: DSI
• 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: Other
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Device Age: 1 YR
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 48 YR