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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOMEDICS WALGREENS BPW920 HOMEDICS BLOOD PRESSURE WRIST AUTOMATIC MONITOR

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HOMEDICS WALGREENS BPW920 HOMEDICS BLOOD PRESSURE WRIST AUTOMATIC MONITOR Back to Search Results
Model Number BPW920
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 08/22/2018
Event Type  Injury  
Event Description
Walgreens wgnbpw920 made by homedics purchased 2 years ago. Device has always given highly variable readings. I do take medicine for blood pressure, and previous spurious readings had me go to the dr complaining of high bp only to find that things were normal. This week i took device out to measure blood pressure and got readings of 182/150 followed by 177/82, followed by 150/120. This is much more variable than i had in the past. I then went to the drug store to get an independent reading - resulting in 220/112 at which point the pharmacist advised me to go to the emergency room where i was treated for uncontrolled blood pressure and spent 2 days in the hosp. This device is unreliable for use by people that need to control their blood pressure, the same people likely to buy it. It did not cause me to go to the hosp, but the preventative purpose of the device failed and left me vulnerable to uncontrolled.
 
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Brand NameWALGREENS BPW920
Type of DeviceHOMEDICS BLOOD PRESSURE WRIST AUTOMATIC MONITOR
Manufacturer (Section D)
HOMEDICS
MDR Report Key7826399
MDR Text Key118768594
Report NumberMW5079448
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBPW920
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

Patient Treatment Data
Date Received: 08/28/2018 Patient Sequence Number: 1
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