MAUDE Adverse Event Report: WITHINGS, INC. PULSE HR ; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

I have a withings pulse hr device made in (b)(6) that has two green led lights that detect blood pulsing in the veins in the back of my wrist to measure my heart rate.Are these led lights regulated? have they been verified for safe use? i have "burns" on both my wrists where the led lights have been applied 24/7 for many weeks.The debate here is the cause of those burns, i say it is the led lights because of the localization of the burns.Other folks tell me it is a metal allergy in which case it should be more widespread on my wrists, and i have no known metal allergies.Withings suggested cleaning with alcohol daily, but this did not stop the problem.I suspect the leds are emitting too strongly the photons necessary to do the task.Fda safety report id #(b)(4).

• Brand Name: PULSE HR
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): WITHINGS, INC.; 2500 bee cave rd ; bldg 1 ste 300; austin TX 78746
• MDR Report Key: 10137912
• MDR Text Key: 194864343
• Report Number: MW5094917
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2020

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 100