MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPEASY SEAT ASSIST PLUS

Model Number CCFUPE3

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vertebral Fracture (4520)

Event Type  Injury  

Event Description

Physical therapist showed her how to use it but didn't tell her that she shouldn't use it in the wheelchair.The first time that she used it, she fell out of the wheelchair she was in.This was in the beginning of july.She injured her spine and needed surgery to fuse her spine.The person reporting it said that there should be a warning on the box.Instructions attached.Safety precautions: page 1 - # 1 the unique patented design of the upeasy seat assist has safety at its core.While upeasy is made to be as safe as possible, there are some precautions you need to take: "1.Make sure you have something to hold on to when getting up.Upeasy seat assist is designed for use on chairs with arms that offer a stable seating surface.Upeasy is not recommended for use in wheelchairs, automobiles, reclining chairs or office chairs with non-lockable wheels.".

Event Description

Device was returned for inspection: inspection observation: item was returned used with normal wear.The customer purchased this product in march.Her physical therapist showed her how to use it but didn't tell her that she shouldn't use it in the wheelchair.The first time that she used it she fell out of the wheelchair she was in.This was in the beginning of july.She injured her spine and needed surgery to fuse her spine.The person reporting it said that there should be a warning on the box.The unit is in great condition.There are no defects with this unit.Conclusion: this unit has no defects, and works as it should.

• Brand Name: CAREX
• Type of Device: UPEASY SEAT ASSIST PLUS
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 10777948
• MDR Text Key: 214328938
• Report Number: 3012316249-2020-00034
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CCFUPE3
• Device Catalogue Number: CCFUPE3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 91