InjuryPUH
FITBIT VERSA
Received Aug 13, 2019 · Event occurred Aug 1, 2019
Report MW5089033 · MDR key 8894344
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR
- Irritation
- Pain
- Loss of Range of Motion
- Irritation
- Pain
- Loss of Range of Motion
Narrative
Description of Event or Problem
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).