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

Model Number 02-01609

Device Problem Biocompatibility (2886)

Patient Problems Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321518053
• Report Number: 2133409-2023-00047
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female