MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC SENSOR PATCH FOR MCOT HEART MONI; DETECTOR AND ALARM, ARRHYTHMIA

Lot Number U210184

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Erosion (2075)

Event Date 07/29/2021

Event Type  Injury  

Event Description

Adhesive from cardiac sensor attached to chest caused serious skin breakdown, with skin erosion, pieces of skin pulling off, with pus and three spots under the sensor.The product was the adhesive patch lot # u210184 by (b)(4).The product, as designed, requires that the monitoring sensor be attached to the chest in a specific location using a provided template the precisely locates the spot on the chest where it must be attached.Since this is the spot where the skin breakdown occurred, we had to terminate the monitoring after three days of use, instead of the planned 30 days.Other similar 30- day heart monitoring systems allow for attachment of the leads in slightly varying locations.The lack of such flexibility with this product meant that monitoring had to be terminated.The monitoring company was notified on 8-2-21 that the monitoring had been terminated.The product was the adhesive patch lot # u210184 by (b)(4).Fda safety report id # (b)(4).

• Brand Name: SENSOR PATCH FOR MCOT HEART MONI
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; eagan MN 55121
• MDR Report Key: 12280644
• MDR Text Key: 265420664
• Report Number: MW5103011
• Device Sequence Number: 1
• Product Code: DSI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: U210184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Weight: 80