MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 WITH UNIVERSAL PATCH ELECTRODE

Model Number 02-01609

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 11/06/2022

Event Type  Injury  

Event Description

Biotel heart patient reported hives started on (b)(6), then became blisters to open burns that are now discharging fluids.Patient's physician told her to call philips to notify.Patient was prescribed anti-itch medication triamcinolone.Patient stated she has a history of skin sensitivity.

Manufacturer Narrative

Customer support ordered flexible patch and cloth electrodes for the patient to continue monitoring.Electrode not returned.For all esi: 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: C6 WITH UNIVERSAL PATCH ELECTRODE
• Type of Device: C6 WITH UNIVERSAL PATCH ELECTRODE
• 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: 15825001
• MDR Text Key: 303907209
• Report Number: 2133409-2022-00014
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: U600955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• 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: 56 YR
• Patient Sex: Female