MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC ELECTRODE - ADAPTER - LEAD WIRE

Model Number 02-00139

Device Problem Biocompatibility (2886)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, the patient was experiencing a rash while wearling the lead wire adapater (lwa).The patient noted that the the rash had spread to the nipple/breast area and bruising was present.They were experiencing bleeding, scrappiness, oozing and rawness that is very painful.The patient contacted their dermatologist regarding the rash and they were prescribed doxycycline to take to relieve irritation.The patient's cardiologist advised the patient to continue monitoring.The patient reported that they have numerous allergies to triple ointment ingredients and latex and a mild adhesive allergy.It is thought the skin irritation is due to the electrodes.

• Brand Name: ELECTRODE - ADAPTER - LEAD WIRE
• Type of Device: ELECTRODE - ADAPTER - LEAD WIRE
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6512968630
• MDR Report Key: 18935598
• MDR Text Key: 338070961
• Report Number: 2133409-2024-00020
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146BTPL20
• UDI-Public: B146BTPL20
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-00139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 01-02108, ELECTRODE - PAD - FOAM - VERMED A10091
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female