MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, EPATCH 2.0, BTH/UNIVERSAL ELECTRODE-PATCH

Model Number 02-01575

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

Engineering evaluation was unable to be performed as the electrode/device was not yet returned.The device has been requested for return to perform further investigation.A follow up report will be sent upon completion of the investigation.

Event Description

The patient reported on (b)(6) 2023 that on (b)(6)they removed due to the malfunction.The patient took off the patch because their chest was burning and felt extremely itchy and that's when the patient saw the patch was covered in brown goo and their skin was blistered and red all over where the epatch monitor was sitting.The patient went to the emergency room and showed them her chest and breast and was told it was a reaction to the battery acid.The patient was prescribed triamcinolone 0.5 % ointment because of how severe the allergic reaction was.The patient also had to use scar cream for her chest because of bad the battery scared her chest.The patient is no longer on service and has returned the kit and does not have a history of skin sensitivities.The patch lot number is unknown as the kit has been returned.

Manufacturer Narrative

Engineering evaluation: device was inspected for general physical integrity, was ok.Device thickness was measured.On contacts side the thickness was 0.420in and on the battery side the thickness was 0.451in.Both measurements were within limits.The seal around the case was inspected for evidence of battery leakage.The seal was intact and it is most probable that there was no battery leakage.Conclusion: engineering evaluation was unable to identify any evidence of case expansion or anything that could have caused or contributed to skin irritation.Any alleged skin irritation is more likely to be caused by a biocompatibility event with the electrode adhesive.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.

• Brand Name: UNIT, EPATCH 2.0, BTH/UNIVERSAL ELECTRODE-PATCH
• Type of Device: UNIT, EPATCH 2.0, BTH/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 dr; suite 150; eagan MN 56121
• MDR Report Key: 16809191
• MDR Text Key: 313945224
• Report Number: 2133409-2023-00017
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146EP2010
• UDI-Public: B146EP2010
• 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,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female