MAUDE Adverse Event Report: CAREX; WHEELCHAIR

Model Number FGA232C0 0000

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994); Swelling (2091); Thrombus (2101)

Event Type  Injury  

Event Description

The screw came out of one of the wheelchair's handles, and the end-user fell - the end-user was hospitalized, had a cat scan and an x-ray, has bruising on her legs, and is now on three different medications.The end-user is reported as trying to transfer from the wheelchair to her bed with the brake locks on.The screws came out that hold the brakes down, and she fell backwards.The wheelchair given to the end-user by the store she bought it from could have been on display - the wheels were a bit wobbly.The user reports pain and suffering, and is now scared to use a new wheelchair, and has to have someone behind her to make sure this type of event/malfunction doesn't happen again.On (b)(6) 2017 compass health brands updated communication with end-user indicated that the user has blood clots on her legs from the fall.She is still in pain on her left side, and her leg has started swelling.She went to the er twice.She thinks the store she bought the wheelchair from gave the wheelchair to her already assembled, as the person brought the chair from the back, and it was already put together - again, she thinks she was given a display chair.She said the wheels were locked when she was getting up from the wheelchair, the wheelchair went back, and she fell.She also indicated that she picks up the wheelchair and puts it in her car.Foot rests are not used on the wheelchair.

• Brand Name: CAREX
• Type of Device: WHEELCHAIR
• MDR Report Key: 7104942
• MDR Text Key: 94483273
• Report Number: 3012316249-2017-00136
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA232C0 0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2017
• Distributor Facility Aware Date: 11/17/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 79