MAUDE Adverse Event Report: CALA HEALTH, INC. CALA TRIO; EXTERNAL UPPER LIMB TREMOR STIMULATOR

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

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Bilateral hand swelling.Fda safety report id# (b)(4).

• Brand Name: CALA TRIO
• Type of Device: EXTERNAL UPPER LIMB TREMOR STIMULATOR
• Manufacturer (Section D): CALA HEALTH, INC.
• MDR Report Key: 14267674
• MDR Text Key: 290685750
• Report Number: MW5109481
• Device Sequence Number: 1
• Product Code: QBC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White