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

Model Number	WPM05
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WITHINGS
• MDR Report Key: 16225616
• Report Number: MW5114424
• Device Sequence Number: 15201940
• Product Code: DXN
• UDI-Device Identifier: 03700546705984
• UDI-Public: (01)03700546705984
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: WPM05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMGALITY ; FISH OIL ; FLEXERIL ; GABAPENTIN ; L-METHYLFOLATE; SYNTHROID ; TRAMADOL ; TYLENOL ; VORTIOXETINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White