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

Model Number	02-02045
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Discomfort (2330); Electric Shock (2554)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 05 february 2024 that the patient was showering on (b)(6) 2024 and felt a shock in her entire body.The patient started shaking and they got out of the shower to make sure they were okay.The patient went back into the shower to rinse off.The patient services rep advised the patient to remove the device and return.A replacement device was ordered.Later on, (b)(6) 2024, a patient service supervisor called the patient back and additional information was received.The patient reported that they were transported to the hospital due to the shock.The patient described shock as if she was having a heart attack or seizure.In the emergency room (er) the patient was given pain meds.The patient was discharged from the hospital and was prescribed fentanyl and aspirin.On (b)(6) 2024 the patient was experiencing similar symptoms to what they had experienced on (b)(6) 2024, and they were no longer comfortable wearing the device.

• 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: 18820293
• Report Number: 2133409-2024-00011
• Device Sequence Number: 11843456
• Product Code: DSI
• UDI-Device Identifier: B146EP2510
• UDI-Public: B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: 02-02045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female