MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH

Lot Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Skin Tears (2516); Skin Inflammation/ Irritation (4545)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

The most probable cause of the the skin condition was attributable to patient pre-existing condition of sensitive skin.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.Patch is unavailable for evaluation.Patient was advised by customer support to switch to usage of the lead wire adapter twice per day to continue usage.Patient was advised on requirement of changing and rotating electrodes and to use water and soap on the skin area.The patient's physician informed the patient to use a prescription cream that the patient already had for a prior inflammatory skin condition.No additional prescription was written.

Event Description

Biotel heart customer support notified braemar that the patient called with skin irritation and some bleeding from the patch and that no skin prep done.Her doctors office used antibacterial gel to treat the skin condition.The doctor informed the patient to use a prescription cream the patient already had for inflammation (betamethasone valerate 0.1%).No additional prescription was written.

• Brand Name: C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH
• Type of Device: C6 WITH E-PATCH V 2.0 UNIVERSAL 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 dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15478562
• MDR Text Key: 300569381
• Report Number: 2133409-2022-00010
• Device Sequence Number: 1
• Product Code: DSI
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• 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: 39 YR
• Patient Sex: Female