Jay Union CushionRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00016958056402), received between Jul 6, 2021 and Apr 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE END USER REPORTS THAT AFTER PIVOTING FROM THE BED ONTO HER WHEELCHAIR AND FASTENING HER POSITIONING BELT, SHE ALLEGEDLY SLID OFF THE SEAT CUSHION AND WAS SUSPENDED ON THE EDGE OF THE WHEELCHAIR FOR 10 HOURS. THE END USER STATED THAT SHE SLID OFF THE CUSHION DUE TO THE WEAR OF THE WHEELCHAIR FITTED CUSHION COVER. THE END USER REPORTS THAT AFTER THE INCIDENT, SHE WAS ADMITTED INTO THE HOSPITAL AND SUBSEQUENTLY A REHAB FACILITY.

  Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19169043 ↗
• MalfunctionAug 13, 2021Material Twisted/Bent; Material Twisted/Bent

  DEALER STATED THAT THE GEL PACKET CAME UNGLUED FROM THE BASE AND ROLLED INTO A BALL CAUSING A PRESSURE POINT ON THE END USER'S BUTTOCK. SKIN WAS NOT BROKEN, THIS WAS NOT A SERIOUS INJURY. HOWEVER, LEFT UNTREATED, IT HAS THE LIKELIHOOD OF PROGRESSING TO A SERIOUS INJURY; THEREFORE, MDR IS BEING FILED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 12318604 ↗
• MalfunctionJul 6, 2021Naturally Worn; Naturally Worn

  DEALER STATED THAT CLIENT HAD SOME SKIN ABRASION WHICH HE DESCRIBED AS SKIN IRRITATION WHICH WAS TREATED THROUGH TOPICAL PRODUCTS THAT HE BELIEVES WAS OBTAINED THROUGH A DOCTOR. HE THINKS SHE SAW A DOCTOR ONE TIME OVER THE ISSUE AND SHE GOT BETTER AFTERWARDS; HOWEVER, HAD TO LIMIT HER TIME IN THE CUSHION. THE ISSUE WAS DESCRIBED, BY THE DEALER, AS "THE FRONT OF THE CUSHION BREAKING DOWN." STATED IN THE BEGINNING CUSHION WAS FINE AND AFTER ABOUT AFTER 6 MONTHS OR SO IT STARTED GETTING COMPRESSED AND ABOUT 6 WEEKS AGO WHEN SHE FIRST CONTACTED DEALER THEY STARTED MONITORING HOW MUCH TIME SHE WAS SPENDING IN THE CHAIR.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 12121423 ↗