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

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.

• Brand Name: ARIA WIFI SMART SCALE
• Type of Device: ANALYZER, BODY COMPOSITION
• Manufacturer (Section D): FITBIT INC; 2995 steven martin drive; fairfax VA 22031
• MDR Report Key: 8227809
• MDR Text Key: 132548013
• Report Number: MW5082917
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 95