• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FITBIT FITBIT CHARGE HR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FITBIT FITBIT CHARGE HR Back to Search Results
Model Number CHARGE HR
Device Problems Self-Activation or Keying (1557); Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Pain (1994); Sleep Dysfunction (2517); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 01/08/2016
Event Type  Injury  
Event Description
I purchased a fitbit hr specifically for the heart rate monitor. It inflamed my carpal tunnel syndrome and left a first degree burn on my wrist. The customer service rep told me to turn off the heart rate monitor, and i told her i'd rather return it. So she told me to try it on my ankle. It also caused pain inside my angle joint, left a painful second degree burn with a blister,a nd caused a painful cut where the latch dug into my skin overnight. I was promised a return authorization, but it never came. Also, the light up display would turn itself on frequently, waking me at night, and causing serious issues with my sleep disorders. The customer service rep said she fixed the setting so it wouldn't do that, but the fix only lasted one night.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFITBIT CHARGE HR
Type of DeviceFITBIT CHARGE HR
Manufacturer (Section D)
FITBIT
MDR Report Key5416678
MDR Text Key37735955
Report NumberMW5060041
Device Sequence Number1
Product Code MNW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCHARGE HR
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-