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

Model Number 02-02045

Device Problem Unintended Electrical Shock (4018)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 02/03/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 336734699
• Report Number: 2133409-2024-00011
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 02-02045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female