MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC BIOTEL HEART UNIVERSAL ELECTRODE PATCH

Lot Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

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

Event Date 02/16/2023

Event Type  Injury  

Event Description

The patient reported burn injury on skin.The patient went to the er to seek treatment.The patient did not follow any skin prep routine.The patient has no history of skin sensitivities.The patient reported burn injury on skin.The patient went to the er to seek treatment.The patient did not follow any skin prep routine.The patient has no history of skin sensitivities.

Manufacturer Narrative

The patient has no history of skin sensitivities.The patient decided to disconnect early and will not be sending images of the skin irritation.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is unable to be confirmed as there are no images of patient skin irritation, and any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.Further attempts to gather information not successful.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: BIOTEL HEART UNIVERSAL ELECTRODE PATCH
• Type of Device: BIOTEL HEART UNIVERSAL ELECTRODE 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: 16524814
• MDR Text Key: 311137144
• Report Number: 2133409-2023-00005
• 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,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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
• Date Manufacturer Received: 02/16/2023
• 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: 75 YR
• Patient Sex: Male