MAUDE Adverse Event Report: LIVING SCIENCE CO., LTD. WALGREENS; DELUXE ARM BLOOD PRESSURE MONITOR

Model Number	WGNBPA-950
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Headache (1880); Intracranial Pressure Increased (4586)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient claimed that they stopped taking their "blood pressure medicine" based on readings from the device.This is direct conflict with two (2) of the first three (3) warnings on page 4 of the instructions for use: "please note that this is a home healthcare product only and it is not intended to serve as a substitute for the advice of a physician or medical professional." "do not use this device for diagnosis or treatment of any health problem or disease.Measurement results are for reference only.Consult a healthcare professional for interpretation of pressure measurements.Contact your physician if you have or suspect any medical problem.Do not change your medications without the advice of your physician or healthcare professional.".
Event or Problem Description
Homedics recevied mdr report # mw5114567 on 2/7/2023.In the report the individual who made the report and wanted to remain confidential claimed the following: "this machine gives me low readings and therefore, i have not taken my blood pressure medication in weeks, and i have been having headaches and pressure in my eyesight." the alleged this was with model #: wgnbpa-950.Note: the individual reported the manufactuer as "homedics group canada".This is not consistent as the model identified (wgnbpa-950) is sold exclusively to walgreens in the us under their private label.

• Brand Name: WALGREENS
• Common Device Name: DELUXE ARM BLOOD PRESSURE MONITOR
• Manufacturer (Section D): LIVING SCIENCE CO., LTD.; no.1428 xiang jiang road; suzhou new district; suzhou city, jiangsu 21512 9; CH 215129
• MDR Report Key: 16405023
• Report Number: 1832894-2023-00002
• Device Sequence Number: 5378796
• Product Code: DXN
• UDI-Device Identifier: 00311917183404
• UDI-Public: 00311917183404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2023
• Report Date (Section F): 02/20/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: WGNBPA-950
• Device Catalogue Number: WGNBPA-950
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2023
• Event Location: Other
• Date Report to Manufacturer: 02/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2023
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2023