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

Model Number	02-01609
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The patient reported a huge bleeding rash after wearing the flex patch for 48hours.The patient was also irritated by the universal patch.The patient reported waiting for 6 days to use another patch due to infected skin.Patient used alternative supplies to continue service.Patient was prescribed a "powder" (nystatin 100,000 unit/gm powder) after seeing the doctor for the irritation of the skin.Patient indicates she has sensitive skin.Skin prep regimen was followed.
Additional Manufacturer Narrative
Removed incorrect patient contact telephone number.

• Brand Name: BIOTEL HEART UNIVERSAL ELECTRODE PATCH
• Common Device Name: 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
• MDR Report Key: 16794741
• Report Number: 2133409-2023-00014
• Device Sequence Number: 15057151
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: 40622V13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2023
• Supplement Date Received by Manufacturer: 04/08/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female