MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE-PATCH

Model Number 02-02045

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2024 by the patient stating that when attempting to remove the sensor from the universal patch the sensor became extremely hot and began smorking.The patient reported they were okay.When the sensor started smoking the patient attempted to remove the sensor by using a pair of twisters and tried to gouge around the blue portion on the universal patch.Soon after the patient realized they were in the worng place.The sesnor was removed and fell.The device was not operation after the event and a replacement device was ordered.No patient harm was reproted.

• Brand Name: UNIVERSAL ELECTRODE-PATCH
• Type of Device: UNIVERSAL ELECTRODE-PATCH
• 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
• MDR Report Key: 18933440
• MDR Text Key: 338338317
• Report Number: 2133409-2024-00019
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146EP2510
• UDI-Public: B146EP2510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-02045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female