MAUDE Adverse Event Report: BIGFOOT BIOMEDICAL,.INC BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

Model Number FG-300203

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Type of Device: DIABETES MANAGEMENT SYSTEM
• Manufacturer (Section D): BIGFOOT BIOMEDICAL,.INC; 1820 mc carthy boulevard; milpitas CA 95035
• MDR Report Key: 15696375
• Report Number: 3016525500-2022-00020
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506371
• UDI-Public: 0100850003506371
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2023
• Device Model Number: FG-300203
• Device Catalogue Number: FG-300203
• Device Lot Number: 17445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR