MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT

Model Number	02-01846
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is confirmed through description of the skin irritation and is most probable to be a bio-incompatibility issue with the electrode adhesive.The patient had preexisting skin sensitivities.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.
Event or Problem Description
Patient reported that was sensor battery was only lasting 2 days and was not given a replacement from agent.After a few more days the sensor got hot and burned her.She said she had blisters under the sensor and electrodes in the patch.She had to take the device off.The patient was advised to take the device off and a replacement device was ordered and patient will switch to lwa (lead wire adapter).Additional information was obtained on 31 may 2023 from patient services and the patient: the patient reported that she was experiencing pain from the area where the patch was "blisters under the patch" and "sensor getting hot after charging," the blisters are like cigarette burns.The patient stated that she will be seeing her family doctor.The patient also stated that she has pre existing skin sensitivities.The patient was prescribed burn ointment and antibiotic steroids cream for second degree burns.
Additional Manufacturer Narrative
Correction: d4.

• Brand Name: UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT
• Common Device Name: UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• MDR Report Key: 17105280
• Report Number: 2133409-2023-00027
• Device Sequence Number: 2834088
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10/$$+7SE23530512O
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01846
• Device Lot Number: B146C6E10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female