MAUDE Adverse Event Report: FITBIT FITBIT CHARGE HR

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.

• Brand Name: FITBIT CHARGE HR
• Type of Device: FITBIT CHARGE HR
• Manufacturer (Section D): FITBIT
• MDR Report Key: 5416678
• MDR Text Key: 37735955
• Report Number: MW5060041
• Device Sequence Number: 1
• Product Code: MNW
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CHARGE HR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 107