MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM; UNIT,C6S 3.0,BTH

Model Number	02-01846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Beginning 15 september 2023, the patient called and emailed to report that they will be returning the device because the second batch of vermed electrodes caused blisters and bleeding from gel that leaked out of the electrodes.The patient saw their doctor, who prescribed clobetasol propionate cream usp,0.05%.After applying it twice daily for 14 days, the patient's skin healed but now has scarring.The patient reported that they cleaned and dried their skin properly before applying the electrodes and has no prior skin sensitivity/allergy.
Additional Manufacturer Narrative
It was reported that the patient wearing vermed electrodes that caused blistered and bleeding.The electrodes and device were not returned for investigation.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is able to be confirmed as there are images of patient skin, and any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.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.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: C6 MCOT PPM
• Common Device Name: UNIT,C6S 3.0,BTH
• 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: 18384673
• Report Number: 2133409-2023-00077
• Device Sequence Number: 17135913
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 07/18/2024

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: 02-01846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2023
• Supplement Date Received by Manufacturer: 03/08/2024; 07/08/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 03/11/2024; 07/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VERMED ELECTRODES, 01-02108, 42622V13
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female