MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC E-PATCH V 2.0 UNIVERSAL PATCH; E-PATCH 2.0

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

The most probable cause of the skin condition was attributable to patient pre-existing condition of very thin skin.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 device is unavailable for evaluation.

Event Description

Biotel heart customer support notified braemar that the patient had gotten a blister, red shape of the patch, and skin was removed and tender to touch.The patient went to urgent care and was provided with antibiotics to for the skin condition.

• Brand Name: E-PATCH V 2.0 UNIVERSAL PATCH
• Type of Device: E-PATCH 2.0
• 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
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15443345
• MDR Text Key: 300121387
• Report Number: 2133409-2022-00009
• Device Sequence Number: 1
• Product Code: DSI
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/18/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female