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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOREPRO FITNESS TRACKER SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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MOREPRO FITNESS TRACKER SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number ASIN: B07FM38DPM
Device Problem Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
(b)(6) is allowing the sale of watches that supposedly take your blood pressure, but these products do not work and provide false numbers based in the initial parameter you must enter at set up. This could be very dangerous for people with heart or other issues that affect blood pressure who need to know where their blood pressure is. Morepro fitness tracker, (b)(6): (b)(4). Fda safety report id # (b)(4).
 
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Brand NameMOREPRO FITNESS TRACKER
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MDR Report Key12354159
MDR Text Key268033890
Report NumberMW5103417
Device Sequence Number1
Product Code DXN
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberASIN: B07FM38DPM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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