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

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 02/25/2021

Event Type  Injury  

Event Description

Patient wears a cala trio device for essential tremor and had a burn from the leads.She stopped wearing the device, contacted the manufacturer and the burn has since healed without any problems.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: 11398342
• MDR Text Key: 234433534
• Report Number: MW5099703
• Device Sequence Number: 1
• Product Code: QBC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 48