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

Model Number FBS04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Loss of Range of Motion (2032)

Event Date 08/01/2019

Event Type  Injury  

Event Description

After i started using the fitbit versa device, i began experiencing sharp pains from my left wrist up through my left shoulder, along with restricted range of motion as a result of the pain and nerve irritation.As soon as i stopped wearing the device, the pain subsided.Fda safety report id # (b)(4).

• Brand Name: FITBIT VERSA
• Type of Device: ANALYZER, BODY COMPOSITION EXEMPT
• Manufacturer (Section D): FITBIT, INC.
• MDR Report Key: 8894344
• MDR Text Key: 154419035
• Report Number: MW5089033
• 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

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: No Information
• Device Model Number: FBS04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR