MAUDE Adverse Event Report: WITHINGS WITHINGS BPM CONNECT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number WPM05

Device Problem High Readings (2459)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

I had been using a withings bpm connect blood pressure cuff.It was reading high which we did not realize until i compared it with the doctor's office blood pressure reading.This resulted in me taking a blood pressure medication for several months when i did not require one.Other than taking a medication i didn't need, no injury was sustained.I reported to withings and have had several emails back and forth without a satisfactory response.

• Brand Name: WITHINGS BPM CONNECT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WITHINGS
• MDR Report Key: 16225616
• MDR Text Key: 307985018
• Report Number: MW5114424
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WPM05
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: EMGALITY ; FISH OIL ; FLEXERIL ; GABAPENTIN ; L-METHYLFOLATE; SYNTHROID ; TRAMADOL ; TYLENOL ; VORTIOXETINE
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White