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

Model Number J2 CUSHION

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Date 09/05/2022

Event Type  Injury  

Manufacturer Narrative

Background information: the age of the cushion at the time of the complaint was 6 months.The expected lifetime of a wheelchair cushion is 2 years.Jay j2, x2, & xtreme cushion owner's manual, rev.O, 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." jay j2, x2, & xtreme cushion owner's manual, rev.O, page 2 states: "warning! your jay cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay cushion is not a substitute for good skin care including, proper diet, cleanliness, and regular pressure relief." jay j2, x2, & xtreme cushion owner's manual, rev.O, page 2 states: "check sitting pressure often! your jay cushion was designed for sitting comfort and postural support.Users should inspect their skin daily for redness.The clinical indicator of 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 dealer reports that the cushion primarily seemed to be manufactured incorrectly where the seams come together and also noted that there were air pockets found that prevented the gel from being evenly distributed throughout the fluid pad.After 3 weeks of use, the end user allegedly developed a pressure sore.The wound was discovered to be located near the anus, directly where the seams come together.According to information provided by the dealer, the end user continued to use the cushion after the pressure sore was discovered.According to the owner's manual, when skin redness is discovered, the end user should discontinue the use of the cushion immediately.At this time, the jay cushion is being returned for further evaluation.Based on the explanation provided, when the cushion is returned, sunrise will complete a root cause analysis related to the manufacturing of the seams and the air pockets in the fluid pad.The wound developed into a stage 3 pressure sore and the latest wound examination report by a wound care specialist states that the wound is healing/progressing.Conclusion: due to the allegation of a serious injury (stage 3 pressure sore) that required medical intervention (wound care by a wound specialist) this mdr is being filed.The cushion is being returned for further evaluation.If new information is discovered during the evaluation, a supplemental report will be filed.

Event Description

Dealer reports that the cushion seemed to be primarily manufactured incorrectly where the seams come together and also noted that there were air pockets found that prevented the gel from filling out the fluid pad correctly.The increased pressure contact allegedly led to the end user developing a pressure sore.The cushion is being returned for further evaluation.

• 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: 16567854
• MDR Text Key: 311527659
• Report Number: 9616084-2023-00002
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J2 CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2022
• 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): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 93 KG