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

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.

• 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
• MDR Report Key: 8876010
• MDR Text Key: 153801858
• Report Number: 2133409-2019-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6S0
• UDI-Public: +B146C6S0
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 900-0634-00
• Device Catalogue Number: 900-0634-00
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2019
• Type of Device Usage: N
• Patient Sequence Number: 1