MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported the patient experienced severe skin irritation causing a tear, blisters and redness.The device was not returned.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is unable to be confirmed as there are no images of patient skin irritation, 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.
Event or Problem Description
Patient reported they were experiencing skin blisters that were the size of the universal patch.The skin appeared with red raised skin with a tear near were the top of the patch would be on the skin and near the bottom it was very red and completely blistered.The patient went to emergency room (er) and was diagnosed with allergic contact dermatitis due to the adhesive on patch.The patient was prescribed hydrocortisone.Lead wire adapter (lwa) and flex was offered and the patient took a break in service until skin completely healed.The patient has a history of allergies.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• 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: 18151217
• Report Number: 2133409-2023-00075
• Device Sequence Number: 6613621
• Product Code: DSI
• UDI-Device Identifier: B146PE21
• UDI-Public: +B146PE21/$$1224P202118/Q40/
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/15/2024

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: 02-01609
• Device Lot Number: P202118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2023
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female