MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT

Model Number 02-01846

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

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

Event Date 03/25/2023

Event Type  Injury  

Event Description

Patient reported that she recently was prescribed to wear your heart monitor for 30 days.Patient could no longer tolerate the heart monitor on skin.Patient stated skin was bright red, burnt and had wire markings.Additional information received 28 march 2023 from patient services from the patient: the patient followed up with their doctor and was instructed to take the following medication which the patient already had from a previous condition: (triamcinolone 2x day up to 14 days 15gs allerergy md otc cortizone).

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.

• Brand Name: UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT
• Type of Device: UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT
• 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: 16795443
• MDR Text Key: 313823299
• Report Number: 2133409-2023-00016
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Device Lot Number: U601392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2023
• 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: 53 YR
• Patient Sex: Female