MAUDE Adverse Event Report: ELEMENT SCIENCE, INC. JEWEL; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number	ES-2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and an investigation was performed.The device was tested and successfully passed all functional tests.The analysis supports jewel performed as intended.The jewel p-wcd system log was extracted and reviewed.The log records show the patient attempted to defer the shock three times.The patient did not push both buttons and only one button was pushed to defer.
Event or Problem Description
The patient's provider notified element science clinical field rep on (b)(6) 2025, that the patient had received a shock and was taken to the er.It is reported at the time of the event, she was yelling and shouting, she heard the jewel alarm and audible notification that the device was preparing to deliver a shock.She was unable to defer and received a shock.The patient went to er and it was reported there was no patient injury.Patient was released from er with no extended hospital stay required.

• Brand Name: JEWEL
• Common Device Name: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ELEMENT SCIENCE, INC.; 301 chesapeake dr; redwood city CA 94063
• Manufacturer (Section G): ELEMENT SCIENCE INC; 301 chesapeake dr,; redwood city CA 94063
• Manufacturer Contact: vis ayer ; 301 chesapeake dr,; redweed city, CA 94063 ; 4158726500
• MDR Report Key: 23889826
• Report Number: 3027605722-2025-00001
• Device Sequence Number: 11929974
• Product Code: MVK
• UDI-Device Identifier: 00850047782007
• UDI-Public: 00850047782007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P230022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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 Expiration Date: 01/29/2026
• Device Model Number: ES-2
• Device Catalogue Number: JWL-1-MDU0-E-01
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White