MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC CHARGE CORD, RED FOR A10E PHONE

Model Number 700-0770-01

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

The patient reported that they went to unplug the monitor and the orange charger cord was so hot it caused blisters on the patient's hand.It is unknown if the patient sought medical attention.Additional information was requested but could not be obtained.

Manufacturer Narrative

It was reported that when the patient went to unplug the device and the orange charger cord was so hot it caused blisters on patient's hand.The device was not returned for investigation.We are doing further investigation for mcto usb-a/ usb-c cables overheating.

Event Description

The patient reported that they went to unplug the monitor and the orange charger cord was so hot it caused blisters on the patient's hand.It is unknown if the patient sought medical attention.Additional information was requested but could not be obtained.

• Brand Name: CHARGE CORD, RED FOR A10E PHONE
• Type of Device: CHARGE CORD, RED FOR A10E PHONE
• 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: 17237773
• MDR Text Key: 318476381
• Report Number: 2133409-2023-00031
• 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: 06/30/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700-0770-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNIT, C6M, A13, V, 02-02118, MT31001471; UNIT, C6M, A13, V, 02-02118, MT31001471
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female