MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE PATCH, 2CH

Lot Number	P201525
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Skin Inflammation/ Irritation (4545)
Date of Event	12/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was using the universal patch (p201525) during the skin irritation.There was a skin prep routine and patient did not report having skin sensitivity.Patient was advised to contact practice before reapplying device and or continuing service.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 experienced an anaphylactic reaction from wearing the patch and received medical treatment in the emergency room.Patient services support (pss) performed multiple attempts to obtain additional information.However, no further details have been received regarding the incident.

• Brand Name: UNIVERSAL ELECTRODE PATCH, 2CH
• Common Device Name: UNIVERSAL ELECTRODE PATCH, 2CH
• 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
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 16134077
• Report Number: 2133409-2023-00001
• Device Sequence Number: 15362579
• Product Code: DSI
• UDI-Device Identifier: B146PE21
• UDI-Public: B146PE21
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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 Lot Number: P201525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/10/2023
• 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: 53 YR
• Patient Sex: Female