MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC EPATCH V2 MB; PATCH IN POUCH ASSY,UNIVERSAL

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that after wearing the sensor for 5 days the patient remroved the patch and noted damaged skin with red small dots.A new patch was placed and after 9 days the patient reported she could not moved the patch.After struggling the patch was removed and blood blisters were noted.Sections of the adhesive were noted still on the patient's skin.The patient called her doctor and was prescribed to use an antibotic cream.
Additional Manufacturer Narrative
It was reported that the patient experienced skin irritation while wearing the universal patch.The patch did not return for investigation.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is confirmed through images of patient skin irritation and is most probable to be a bio-incompatibility issue 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: EPATCH V2 MB
• Common Device Name: PATCH IN POUCH ASSY,UNIVERSAL
• 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: 17573952
• Report Number: 2133409-2023-00047
• Device Sequence Number: 8400306
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 02-01609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female