Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") ES-2Recalls & reported problems
Element Science, Inc. · ES-2 Reusable Defibrillator Unit, Packaged · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00850047782007), received between Dec 24, 2025 and Sep 30, 2026 — classified as 1 death, 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Circuit Failure6
- Electrical /Electronic Property Problem6
- Adverse Event Without Identified Device or Use Problem1
- Human-Device Interface Problem1
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954722 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954715 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954714 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954713 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954711 ↗MalfunctionSep 11, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744467 ↗MalfunctionSep 2, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571401 ↗DeathJul 10, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT'S EMERGENCY CONTACT REPORTED TO ELEMENT SCIENCE CUSTOMER SERVICE THAT THE PATIENT PASSED AWAY AT HOME ON (B)(6) 2026. ELEMENT SCIENCE OBTAINED THE FOLLOWING INFORMATION FROM THE PRESCRIBER: PCP REPORTED NATURAL CAUSE OF DEATH DUE TO PROBABLY FATAL CARDIAC ARRHYTHMIA SECONDARY TO NON-ISCHEMIC CARDIOMYOPATHY.
Patient problems: Insufficient Information
MAUDE report 25788330 ↗InjuryApr 14, 2026Human-Device Interface Problem
THE PATIENT'S DOCTOR NOTIFIED ELEMENT SCIENCE TERRITORY MANAGER ON (B)(6), 2026, THAT THE PATIENT HAD RECEIVED A SHOCK AND WENT TO THE ER. IT IS REPORTED AT THE TIME OF THE EVENT, PATIENT WAS WALKING BACK FROM THE RESTROOM EARLY IN THE MORNING. THEY HEARD THE JEWEL ALARM AND AUDIBLE NOTIFICATION THAT THE DEVICE WAS PREPARING TO DELIVER A SHOCK. THEY WERE UNABLE TO DEFER AND RECEIVED A SHOCK. THE PATIENT WENT TO THE ER AND IT WAS REPORTED THERE WAS NO PATIENT INJURY. PATIENT WAS OBSERVED OVERNIGHT AND THEN RELEASED FROM ER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878095 ↗InjuryDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889826 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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