MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC JAY SEATING CUSHION; WHEELCHAIR CUSHION

Model Number JAY SOFT COMBI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 08/29/2023

Event Type  Injury  

Event Description

End user reports that he has allegedly developed pressure sores when using his most recent jay soft combi cushion.The end user stated that he believed he selected the incorrect cushion when ordering.The cushion reportedly pushed the end user higher up in the chair and caused rubbing on the back of his jeans.Also, the end user stated the raised sides of the edges caused friction.The reported pressure sores are located on the user's tailbone and thigh.The end user is receiving wound care from a nurse and visits a wound specialist.The end user ordered a new cushion that he will begin to use.

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was approximately 8 months and 6 days.According to the user, the cushion was in use for 3 months.The expected lifetime of a wheelchair cushion is 2 years.Jay soft combi cushion owner's manual states: "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." discussion: in reviewing the complaint, the end user reports that he has allegedly developed pressure sores after using the jay soft combi cushion; this is the second time that this end user has used this particular cushion the end user previously had the same brand of cushion for 11 years before ordering a new one in (b)(6) 2022.The end user stated that he believed he selected the incorrect cushion when ordering online.He mentioned that the foam from the newer cushion was different from the foam in his previous cushion.The newer cushion reportedly pushed the end user higher up in the chair and caused rubbing on the back of his jeans.Also, the end user stated the raised sides of the edges caused friction.The alleged pressure sores are located on the user's tailbone and thigh.The end user stated that because he did not see the pressure sores due to the location, he did not realize they were there.The end user did not know what stage each of the pressure sores were, but he believed the sore on his tailbone allegedly almost went to the bone.The end user receives wound care from a nurse two times a week and visits a wound specialist once a month.The pressure sores are reportedly healing well but the sore on the end user's hip is taking longer than the sore on his tailbone.The end user mentioned that he only used the newer cushion for 3 months and went back to his previous cushion.Sunrise medical does not recommend using a wheelchair cushion past its lifetime.The end user stated that he did order a new cushion (newer than the previous two discussed-his third jay cushion) recently and will be using it in the presence of his home health nurse to monitor for any new/further skin redness as stated in the jay soft combi owner's manual.Conclusion: the information in the complaint indicates the most probable cause as user error due to choosing the incorrect size when ordering the cushion online.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.Based on the allegation of serious injuries that require medical intervention, this mdr is being filed.

• Brand Name: JAY SEATING CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 17835528
• MDR Text Key: 324497461
• Report Number: 9616084-2023-00048
• Device Sequence Number: 1
• Product Code: IMP
• UDI-Device Identifier: 00016958050103
• UDI-Public: 00016958050103
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY SOFT COMBI
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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): Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 54 KG