MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 WITH UNIVERSAL ELECTRODE PATCH; C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH

Lot Number P200999

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(4) was not returned for engineering evaluation.Sensor does not make continuous contact with the patient skin during use and is not likely to cause a skin irritation.For shock, sensor complies with iec 60601-2-47 for medical device safety.Additionally according to iec 60601 the device is considered a low voltage medical device powered at dc 3.7volts (device criteria for low voltage >7.2v).Considering the devices low voltage, the device is unlikely to be the source of a perceptible shock.Electrode p200999 makes continuous contact with patient skin and the patient likely had an adverse reaction to 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 patient skin irritation has been resolved and is currently using a replacement device.

Event Description

Biotel heart customer support notified braemar that the patient called with skin irritation and what felt like being shocked two times from the sensor.Patient consulted a clinician and was prescribed cortisone cream for medical treatment.Patient skin irritation has been resolved and is currently using a replacement device.

• Brand Name: C6 WITH UNIVERSAL ELECTRODE PATCH
• Type of Device: C6 WITH E-PATCH V 2.0 UNIVERSAL 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
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15736395
• MDR Text Key: 303093308
• Report Number: 2133409-2022-00012
• 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: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: P200999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2022
• 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: 69 YR
• Patient Sex: Male