MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC PATCH - UNIVERSAL 2 CHANNEL; UNIVERSAL ELECTRODE-PATCH

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 29 april 2024 the patient noticed blisters, itchy, raw skin that hurts.The patient did not use any over the counter (otc) treatments.The patient did report that they had pre-existing skin sensitivities.The patient was taking a break in service and was going to switch to leadwire adapter (lwa).On (b)(6) 2024 the patient followed up and reported that they cleaned their skin using soapy water, alcohol pads and then cleaned again with warm soapy water and dried.The patient was also given a prescription for triamcinolone.
Additional Manufacturer Narrative
It was reported that patient experienced blisters, itchiness and raw skin due to the universal patch.The universal patch was not returned for evaluation.Engineering evaluation was unable to be performed on the patch as it is single use and was not returned.Allegation is confirmed through images of patient skin irritation attached to this case or a prescription from a medical professional and is most probable to be a bio-incompatibility issue with the electrode adhesive and/or hydrogel components.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: PATCH - UNIVERSAL 2 CHANNEL
• Common Device Name: 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 drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 19510219
• Report Number: 2133409-2024-00033
• Device Sequence Number: 19696796
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: U602696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female