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

Lot Number P201136

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

Patient Problems Cellulitis (1768); Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 09/06/2022

Event Type  Injury  

Event Description

Biotel heart customer support notified braemar that the patient noticed that the adhesive on the patch literally melted into his skin.He was able to remove the sensor but had to take a trip to the emergency room to get the patch removed.The emergency doctor diagnosed patient with cellulitis and contact dermatitis and prescribed keflex 500mg oral medication and silvadene 1% topical cream for his skin.

Manufacturer Narrative

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 has been requested for return, but has not yet been retruned for evaluation.

Manufacturer Narrative

Sensor ((b)(6)) - engineering evaluation was unable to be performed as the device has not been returned.The images of the patient's skin show the damage to be in the same shape as the specific adhesive which is located directly under the sensor and the sensor images do not show signs of damage.It is unlikely that the sensor is the source of the skin irritation.Electrode (p201136) - engineering evaluation was unable to be performed as the device was not returned.Electrode is a single use device and makes continuous contact with a patient's skin.The most probable cause of the skin issue is that the patient experienced a bio-incompatibility event to the electrode adhesive.The device did not exhibit a malfunction due to continued usage.The electrodes were not available for return by patient as these are single use devices.Patient discontinued usage of the device.

Manufacturer Narrative

It was reported that the patient keeps getting alerts from their sensor and noticed that the adhesive on the patch was melting onto their skin.The patch itself was not returned however the sensor was returned for evaluation.The device was production tested and no problems were found.Engineering evaluation was unable to identify any issues with the sensor.

• 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: 15440739
• MDR Text Key: 300077840
• Report Number: 2133409-2022-00008
• 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,Followup,Followup
• Report Date: 08/23/2023

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: P201136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 08/08/2023
• Supplement Dates FDA Received: 12/22/2022; 08/23/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: C6S 2.5, BTH 02-01606, (B)(6)
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Male