Jay Easy CushionRecalls & reported problems
Sunrise Medical (US) LLC · The JAY Easy is a skin protection and positioning wheelchair cushion featuring a high-resiliency, contoured foam base that accommodates a curved or flat seat. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00016958047158), received between Oct 4, 2023 and Oct 4, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Burn(s)1
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2023Use of Device Problem; Use of Device Problem
THE SWEDISH MEDICAL PRODUCTS AGENCY REPORTED TO SUNRISE GERMANY THAT AN INCIDENT OCCURRED WITH AN END USER AND A JAY EASY CUSHION. THE END USER REPORTED THAT WHILE SITTING IN HIS WHEELCHAIR ON THE BALCONY AND SMOKING A CIGARETTE, HE NOTICED THE SEAT UPHOLSTERY BEGAN TO BURN. THE WHEELCHAIR THAT THE END USER WAS USING IS NOT A SUNRISE MEDICAL PRODUCT. THE END USER ALLEGEDLY SUSTAINED BURNS ON THE BACK OF BOTH OF HIS THIGHS. THE JAY EASY CUSHION COMPLIES WITH (B)(4) AND IS FLAME RETARDANT. THE CUSHION WAS RETURNED TO SUNRISE MEDICAL FOR EVALUATION.
Patient problems: Burn(s); Full thickness (Third Degree) Burn
MAUDE report 17871377 ↗
Other Cushion, Wheelchair devices
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- Jay Union CushionSunrise Medical (US) LLC · Cushion, Wheelchair3 reports
- Matrx-Vi Cushion MA-ViMotion Concepts Inc · Cushion, Wheelchair2 reports
- MEDLINE MSCPRC31816CSMedline Industries, Inc. · CUSHION, WHEELCHAIR1 report
- Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoSunrise Medical (US) LLC · Cushion, Wheelchair1 report
- MEDLINE MSCPRC21816CSMedline Industries, Inc. · CUSHION, WHEELCHAIR1 report
- Matrx E2 Standard Back E2SMotion Concepts Inc · Cushion, Wheelchair1 report
- Invacare® ContourU® Naked Back CM02BInvacare Corporation · CUSHION, WHEELCHAIR1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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