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

Model Number 02-01609

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

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

Event Date 04/05/2023

Event Type  Injury  

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 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.

Manufacturer Narrative

Removed incorrect patient contact telephone number.

• 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
• MDR Report Key: 16794741
• MDR Text Key: 313813120
• Report Number: 2133409-2023-00014
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/08/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 04/08/2023
• Supplement Dates FDA Received: 04/24/2023
• 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: 77 YR
• Patient Sex: Female