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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FITBIT INC ARIA WIFI SMART SCALE ANALYZER, BODY COMPOSITION

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FITBIT INC ARIA WIFI SMART SCALE ANALYZER, BODY COMPOSITION Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 01/02/2019
Event Type  Injury  
Event Description
I am not sure if this qualifies but there is a serious problem with fitbit watches. A couple months ago i was having random times where my nerve hurt right under my fitbit. That is the only way to explain it, it didn¿t feel muscle or skeletal. It felt like nerves were hurting. Then i woke up in the middle of the night with my hand in a lot of pain, enough where i couldn't sleep. I took off the fitbit watch and the pain slowly subsided. I never had any problems with that type of pain until i started wearing the fitbit watch again a couple weeks ago. I slowly felt it creeping on again until last night i woke up in the middle of the night with the same pain that isn¿t tolerable to sleep with. I took off the watch and will not wear it again. I looked through the fitbit forums and see literally hundreds of threads with hundreds of comments. Some of the threads seem a little exaggerated along with the comments, but if you look at the overall population, there is a lot of people who are having 'nerve type pain' while wearing the fitbit for long periods of time (and some short periods). The reason i feel like it is necessary for the fda or similar to step in is because, this not a onetime adverse event, this is hundreds of people complaining of a pain that fitbit's device is causing. Some people are not very intelligent and are doing things that could possibly harm them. People are switching the fitbit from hand to hand every day to get rid of the discomfort/pain. Others are just wearing it for a few days until it hurts and then removing it for a couple weeks. Also fitbit is very good at giving refunds or replacements at the drop of a hat. If you are getting very low complaints on this issue, that may be the cause. (which made me hesitate to contact you in the first place. However, i am an employee at a cgmp pharmaceutical manufacturer and now it is my duty to contact about ae's) the fitbit moderators commonly list that all watches are well below some type of electric radiation levels that is set by the fda. However i am concerned of a possibly low dose overlong period of time problem. I wore this fitbit (blaze) for a year until i started to get the discomfort. Again, i removed it for a couple of months and didn't have a problem. Put it back on, and a week or so, i am having the same discomfort. Is the product over-the-counter? yes. Did the problem stop after the person reduced the dose or stopped taking or using the product? yes. Did the problem return if the person started taking or using the product again? yes. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product? (b)(6) 2018.
 
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Brand NameARIA WIFI SMART SCALE
Type of DeviceANALYZER, BODY COMPOSITION
Manufacturer (Section D)
FITBIT INC
2995 steven martin drive
fairfax VA 22031
MDR Report Key8227809
MDR Text Key132548013
Report NumberMW5082917
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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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