MAUDE Adverse Event Report: OMRON HEALTHCARE COMPANY OMRON BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number BP 7250

Device Problem Increase in Pressure (1491)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 09/11/2022

Event Type  Injury  

Event Description

By recommendation from primary care provider (pcp), i purchased a unit of blood pressure monitor.I picked up omron cuff blood pressure monitor (model bp7250, made in vietnam) from walmart, (b)(6) several months ago.I reporting only one month data to pcp.After that due to very uncomfortable condition it produces (very tight squeeze like being constricted by a bore constrictor snake, holds my arm longer than that at pcp's office before finally releasing me from the high pressure), i was using it only a few times a week, either bedtime or at wake up.On the night (b)(6) 2022 i used it.Next morning while dressing i noticed: the region between wrist and elbow of my left arm was warm to the touch, hardened up, pain, inflamed with 1 inch larger circumference as compared to other arm in the same location, and elbow bends roughly.Applied ice pack and had bed rest.Reported it on the manufacturer omron website.Fda safety report id# (b)(4).

• Brand Name: OMRON BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): OMRON HEALTHCARE COMPANY
• MDR Report Key: 15454996
• MDR Text Key: 300317515
• Report Number: MW5112122
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BP 7250
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 56 KG