MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC JAY(R) UNION(TM) WHEELCHAIR CUSHION

Model Number Jay Union Cushion

Device Problem Naturally Worn (2988)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

Background information: fogelberg, atkins, blanche, carlson, and clark (decisions and dilemmas in everyday life: daily use of wheelchairs by individuals with spinal cord injury and the impact on pressure ulcer risk.Topics in spinal cord injury rehabilitation, 15(2), 16- 32.Doi: 10.1310/sci1502-16) determined that the lifetime incidence, in individuals that use wheelchairs due to spinal cord injuries, have a 95% chance of developing a pressure sore/injury/ulcer.This is primarily due to the fact that full-time wheelchair users must perform all daily routines while confined to a seated position for most waking hours.Due to lack of physical sensation, persons with these impairments may not move their positions often enough to remove pressure from areas of risk (e.G., areas over bony prominences such as the sacrum, coccyx, trochanters, etc.) to allow for continuous blood circulation to the skin overlying these structures.As a result, skin breakdown can occur.Webmd defines four levels of pressure sores: stage 1: this is the mildest stage.These pressure sores only affect the upper layer of skin.Symptoms may include pain, burning, or itching.The spot may also feel different from surrounding skin: firmer or softer, warmer or cooler.The skin may also look reddened or may get not get lighter when you press on it (blanch) or even 10-30 minutes after pressure is removed.This may require gentle skin cleaning and care, but no medical intervention is required.Stage 2: skin is broken, leaves an open wound, or looks like a pus-filled blister.The area is swollen, warm, and/or red.The sore may ooze clear fluid or pus.This requires wound treatment, but may not require medical intervention unless patient or caregiver is unable to perform routine wound care.The wound is painful (in non-plegics).3.Stage 3: these sores have gone through the second layer of skin into the fat tissue.The sore looks like a crater and may have a bad odor.It may show signs of infection: red edges, pus, odor, heat, and/or drainage.The tissue in or around the sore is black if it has died.This level requires treatment by a medical professional to remove any dead tissue and to prescribe antibiotics, if infected.This stage requires ongoing medical intervention for 1-4 months to heal.Stage 4: these sores are the most serious.Some may even affect muscles and ligaments.The sore is deep and big.Skin has turned black and shows signs of infection -- red edges, pus, odor, heat, and/or drainage.You may be able to see tendons, muscles, and bone.These wounds require medical intervention (up to and including surgery) to repair the damage.This stage requires ongoing medical intervention for 4-12 months to heal.Many factors can contribute to skin breakdown in persons confined to a wheelchair for most waking hours.These factors include, length of time spent in a seated position, make-up of materials upon which end user is seated, pressure relief activities, repositioning activities, sensation, circulation, etc.Since the seat cushion only makes up one portion of the factors that may contribute to skin breakdown, there is a strong belief that the user must contribute to their own health through regular intervals of pressure relief and repositioning.The most comfortable wheelchair cushion in the world will not prevent skin breakdown in an end user that does not perform their activities to relieve pressure.Therefore, there is no expectation that a seating cushion has malfunctioned if skin breakdown occurs.Sunrise medical, as a practice, reports all pressure sores that break through the skin (stage 2 and above) as a "serious injury" because this level of injury requires intervention to ensure they do not progress.Jay® union¿ cushion owner manual (part no.: 120023, rev a, page 2) states: "warning: prior to prolonged sitting, any cushion should be tried for a few hours at a time while a clinician inspects your skin to ensure that red pressure spots are not developing.You should regularly check for skin redness.The clinical indicator for tissue breakdown is skin redness.If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist.The jay union cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay union cushion is not a substitute for good skin care including; proper diet, cleanliness, and regular pressure relief." jay cushions are designed to last up to two years without breakdown.The age of the product at the time of the complaint is (b)(6) months of age.Discussion: this cushion shows early breakdown and, therefore, meets the criteria for a malfunction.While the pressure sore suffered in this case was most likely (based on the description of not requiring ongoing medical intervention) a stage 1.However, an untreated stage 1 pressure sore can possibly progress to a more serious level.Therefore, this mdr is being filed out of an abundance of caution.Conclusion: the jay union cushion has broken down prior to its lifetime and, therefore, meets the criteria of a malfunction.No serious injury was incurred.

Event Description

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.

• Brand Name: JAY(R) UNION(TM) WHEELCHAIR CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• MDR Report Key: 12121423
• MDR Text Key: 281649703
• Report Number: 9616084-2021-00010
• Device Sequence Number: 1
• Product Code: IMP
• UDI-Device Identifier: 00016958056402
• UDI-Public: 00016958056402
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Jay Union Cushion
• Device Catalogue Number: BJU2219
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 159