• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BRAEMAR MANUFACTURING, LLC SENSOR PATCH FOR MCOT HEART MONI DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENSOR PATCH FOR MCOT HEART MONI
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
eagan MN 55121
MDR Report Key12280644
MDR Text Key265420664
Report NumberMW5103011
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received08/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberU210184
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/04/2021 Patient Sequence Number: 1
-
-