inforMED
InjuryQBC

CALA TRIO

Received May 2, 2022

Report MW5109481 · MDR key 14267674

Device

Generic name

External Upper Limb Tremor Stimulator

Manufacturer

Cala Health, Inc.

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

77 YR · Male

  • Swelling/ Edema
  • Swelling/ Edema

Narrative

Description of Event or Problem

BILATERAL HAND SWELLING. FDA SAFETY REPORT ID# (B)(4).