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

Catalog Number 100-0028-02

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Complaint handling evaluation: the affected device has not been returned for evaluation to the manufacturer at the time of this report.A follow-up report may be submitted if braemar manufacturing, llc becomes aware of any additional information.Ifu provides warning indications for discontinuing use and contacting a medical practitioner or customer service in the event that severe skin irritation occurs.No additional information is known to braemar manufacturing, llc at this time.

Event Description

On (b)(6) 2019, braemar manufacturing, llc was made aware of patient allegation of burn/skin reaction.The patient allegedly wore a c5 unit and indicated that her skin reacted adversely to the monitor and that she experienced a skin burn.Note: the date of the event is unknown to braemar manufacturing, llc.The become aware date is (b)(6) 2019.

• 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: 8527713
• MDR Text Key: 142370585
• Report Number: 2133409-2019-00002
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093288
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 100-0028-02
• Was Device Available for Evaluation?: No
• Device Age: 4 YR
• Date Manufacturer Received: 03/19/2019
• 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: 57 YR