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

Lot Number P201525

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Anaphylactic Shock (1703); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Skin Inflammation/ Irritation (4545)

Event Date 12/26/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 307040300
• Report Number: 2133409-2023-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE21
• UDI-Public: B146PE21
• 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: 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
• Device Operator: Lay User/Patient
• Device Lot Number: P201525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/10/2023
• 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