MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT; USB CHARGING CORD - SENSOR V2.0 NO USB

Model Number 700-0718-01

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The patient reported that the duel usb charging plug was disintergrating in the wall outlet.It basically crumbles into pieces.The patient was not injured.The device will be returned and a new charger was sent.

Manufacturer Narrative

It was reported that the dual charging adapter disintergrated when plugged into the wall outlet.The device was not returned for investigation.Engineering evaluation is unable to be performed as the device was not returned for evaluation.The allegation is unable to be confirmed as the device was not returned.

• Brand Name: C6 MCOT
• Type of Device: USB CHARGING CORD - SENSOR V2.0 NO USB
• 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: 17572007
• MDR Text Key: 321420422
• Report Number: 2133409-2023-00045
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700-0718-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female