MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, EPATCH 2.0, BTH

Model Number 02-00105

Device Problem Overheating of Device (1437)

Patient Problem Skin Burning Sensation (4540)

Event Type  malfunction  

Event Description

The patient's mother reported that her daughter has been complaining that the device felt like it was burning her skin.The patient's mother thought it was reaction to the adhesive but when she touched the sensor it was "red hot".After the patient removed the patch and sensor, it could be seen that the patient's skin was very red and was burned/injured.The patient's mother reported that the back of the sensor looked "black".Pictures were sent by patient's mother and received on (b)(6) 2023 and confirmed that the back of the sensor near the contact points had visible black color.The patient did not seek medical attention.Lead wire adapter (lwa) were offered and ordered for the patient.The patient took a break in service till the replacement device was received.

Manufacturer Narrative

It was reported that the device was burning the patient's skin.The sensor was not returned for investigation however, pictures were provided.Engineering evaluation was unable to be performed as the device was not returned.Images were sent and it was noted that there was evidence of the sensor heating up, which confirms overheat.It is most probable that the battery is experiencing a failure as the evidence of overheat is nearest the battery.The allegation was able to be confirmed although the root cause of the device melt was unable to be determined.

• Brand Name: UNIT, EPATCH 2.0, BTH
• Type of Device: UNIT, EPATCH 2.0, BTH
• 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: 17266125
• MDR Text Key: 319094975
• Report Number: 2133409-2023-00030
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-00105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 11 YR
• Patient Sex: Female