MAUDE Adverse Event Report: CALA HEALTH INC CALA KIQ; EXTERNAL UPPER LIMB TREMOR STIMULATOR

Model Number	TLA-3268, TLA-3270, TLA3269
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare provider's office reported that a patient was hospitalized with afib requiring a cardioversion after using the device.The patient stopped using the device due to this issue.The patient's spouse reported a history of afib and uncertainty about whether the recent episode was caused by device usage.Initially, the patient used the device regularly without issue and wished to continue use due to favorable results with the therapy, pending the healthcare provider's recommendation.The healthcare provider subsequently recommended that the patient return the device and discontinue service.The return and cancellation were processed, and the spouse was informed about the return process.

• Brand Name: CALA KIQ
• Common Device Name: EXTERNAL UPPER LIMB TREMOR STIMULATOR
• Manufacturer (Section D): CALA HEALTH INC; 1800 gateway dr; suite 120; san mateo CA 94404
• Manufacturer (Section G): CALA HEALTH INC; 1800 gateway drive; suite 120; san mateo CA 94404
• Manufacturer Contact: kevin ung ; 1800 gateway; suite 120; san mateo, CA 94404 ; 4158903961
• MDR Report Key: 22288053
• Report Number: 3011628389-2025-00001
• Device Sequence Number: 18361848
• Product Code: QBC
• UDI-Device Identifier: 00851749007412
• UDI-Public: 00851749007412
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K222237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: TLA-3268, TLA-3270, TLA3269
• Device Lot Number: 2410161001, 2411181002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 93 KG