MAUDE Adverse Event Report: UNKNOWN MMIZOO BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number B07X7W52VQ

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Good day, sir, asin: b09dfyszfs, brand: mmizoo asin: b09dfyszfs, brand: amz vision i bought two different brands of blood pressure monitors on amazon, but i was shocked to discover that both of them gave inaccurate readings, and then i discovered they are made of rough plastic with no manufacturer information, and i am very concerned about their eligibility to sell in the united states.I looked up the relevant information at https://www.Fda.Gov/medical-devices/device-labeling/general-device-labeling-requirements and found that "the label of a device shall contain the name and place of business of the manufacturer, packer, or distributor, including the street address, city, state, and zip code." i've attached photos of the monitor and the package for your review, and i hope your department will take action to stop the sale of medical devices that lack the name and place of business.This is risky.Thank you.(b)(6) additional comments: inaccurate readings.Fda safety report id #(b)(4).

Event Description

Additional information received from reporter on 12/27/2022 for mw5113371.

• Brand Name: MMIZOO BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15825755
• MDR Text Key: 304113422
• Report Number: MW5113371
• 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: 11/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: B07X7W52VQ
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male