MAUDE Adverse Event Report: FITBIT, INC. FITBIT CHARGE 2; ANALYZER, BODY COMPOSITION EXEMPT

Model Number FITBIT 2 CHARGE

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 08/28/2019

Event Type  Injury  

Event Description

While sleeping, i was awoken by a strong electrical shock coming from my fitbit charge 2 watch.It was more than a static electrical shock, but less than a 110 outlet shock.It lasted for several seconds and didn't leave any burn marks on my wrist.I am now afraid to wear this watch because of fear that it might happen while i am driving.Looked up fitbit complaint line and they blame shocks from static electricity.I could see static happening in the winter months, but not in the summer months.Fda safety report id # (b)(4).

• Brand Name: FITBIT CHARGE 2
• Type of Device: ANALYZER, BODY COMPOSITION EXEMPT
• Manufacturer (Section D): FITBIT, INC.
• MDR Report Key: 8960285
• MDR Text Key: 156612443
• Report Number: MW5089523
• Device Sequence Number: 1
• Product Code: PUH
• Combination Product (y/n): N
• 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: 08/30/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FITBIT 2 CHARGE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 68