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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SERIES 600 BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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SERIES 600 BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number BP3MV1-3XCVS
Device Problem Pressure Problem (3012)
Patient Problem Bruise/Contusion (1754)
Event Date 09/22/2020
Event Type  Injury  
Event Description
I bought a bp monitor from cvs model #bp3mv1-3xcvs and after using it few times, noticed it was bruising my arm. I am not at all frail and i do not bruise easily. The device uses a cuff that concentrates all the pressure in one small band. I think the design is defective. Fda safety report id# (b)(4).
 
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Brand NameSERIES 600 BLOOD PRESSURE MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
MDR Report Key10642766
MDR Text Key210628352
Report NumberMW5097132
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBP3MV1-3XCVS
Device Catalogue Number800230
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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