MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT,C6 3.0,BTH

Model Number 02-01846

Device Problem Battery Problem (2885)

Patient Problem Blister (4537)

Event Date 06/18/2023

Event Type  Injury  

Event Description

The patient's father reported that he was changing the patient's patch and there was a quarter-sized blister on the patient's chest where the sensor had been.The patient's father stated that there is battery acid type of residue on sensor connectors.The patient was brought to the emergency room (er) by mother.The patient was given bacitracin antibiotic ointment by er doctor.The device was removed and the a replacement device was sent.

Manufacturer Narrative

It was reported that the patient got a quater-sized blister due the sensor possibly leaking battery acid.The devcie was retruend for investigation.Device was opened to visually inspect for damage and corrosion that could have cause or contributed to a leakage from within the device, the battery showed no signs of leakage.Engineering evaluation was unable to confirm issue with the device leaking.Any alleged skin irritation is most probable to be a biocompatibility event with the electrode adhesive.

• Brand Name: UNIT,C6 3.0,BTH
• Type of Device: UNIT,C6 3.0,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: 17324385
• MDR Text Key: 319274559
• Report Number: 2133409-2023-00038
• Device Sequence Number: 1
• Product Code: DSI
• 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,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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): Hospitalization
• Patient Age: 19 DA
• Patient Sex: Female