MAUDE Adverse Event Report: HOMEDICS GROUP CANADA BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number WGNBPA-950

Device Problem Low Readings (2460)

Patient Problem Headache (1880)

Event Description

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.

Event Description

Additional information received from reporter on 02/09/2023 for mw5114567.My blood pressure has been registering very low numbers, and therefore causing me to not take my blood pressure medication in fear of my heart stopping.If i don't hear back from this company i will be seeking a lawyer's advice.

• Brand Name: BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): HOMEDICS GROUP CANADA
• MDR Report Key: 16272029
• MDR Text Key: 308581493
• Report Number: MW5114567
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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?: No
• Device Model Number: WGNBPA-950
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2023
• Patient Sequence Number: 1