MAUDE Adverse Event Report: Element Science, Inc. Jewel; Wearable Cardioverter Defibrillator

Model Number	ES-2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: Jewel
• Common Device Name: Wearable Cardioverter Defibrillator
• Manufacturer (Section D): Element Science, Inc.; 301 chesapeake drive; redwood city 94063
• Manufacturer (Section G): Element Science, Inc.; 301 chesapeake drive; redwood city 94063
• Manufacturer Contact: vis ayer ; 301 chesapeake dr; redwood city 94063 ; +1(415)872-6500
• MDR Report Key: 50744467
• Report Number: 3027605722-2026-00005
• Device Sequence Number: 18683599
• Product Code: MVK
• UDI-Device Identifier: 00850047782007
• UDI-Public: 00850047782007
• Combination Product (Y/N): N
• 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: Consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ES-2
• Device Catalogue Number: JWL-1-MDU0-E01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2026
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 200 LB
• Patient Race: White