MAUDE Adverse Event Report: SUNRISE MEDICAL JAY J2 DEEP CONTOUR CUSHION; CUSHION, WHEELCHAIR

Model Number Q6 EDGE

Device Problem Unintended System Motion (1430)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

Caregiver states the consumer is using a pride quantum chair with a j2 deep contour cushion and the gel in the cushion is moved to one side which is causing sores on the end users bottom.Caregiver states she is there tending to the sores now.Caregiver found the number to pride on the back of the chair and then advised she will contact them now to inquire how to fix this.No additional information provided.Invacare prid#: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: JAY J2 DEEP CONTOUR CUSHION
• Type of Device: CUSHION, WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL
• MDR Report Key: 17536419
• MDR Text Key: 321148378
• Report Number: MW5143307
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: Q6 EDGE
• Patient Sequence Number: 1