MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC JAY FUSION CRYO; WHEELCHAIR CUSION

Model Number JAY FUSION CRYO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 01/15/2021

Event Type  Injury  

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).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.Conclusion: while there does not appear to be any specific malfunction of this product and, in this user's case, any potential contribution to the injury by the jay fusion cryo cushion cannot be excluded; therefore, this case is being reported as an injury incident out of an abundance of caution.The end user claims that there was no medical treatment provided or prescribed for this injury; therefore, sunrise medical considers this investigation complete and will close the complaint file.

Event Description

End user developed a pressure sore after using a jay fusion cryo cushion on his wheelchair for an approximate time period of two months.

• Brand Name: JAY FUSION CRYO
• Type of Device: WHEELCHAIR CUSION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328 ; 5592942374
• MDR Report Key: 11709016
• MDR Text Key: 253612053
• Report Number: 9616084-2021-00004
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY FUSION CRYO
• Device Catalogue Number: 5990
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 98