MAUDE Adverse Event Report: CAREX; DELUXE FOLDING COMMODE

Model Number FGB34100 0000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348); Cognitive Changes (2551)

Event Type  Injury  

Event Description

The initial reporter states that the right leg of the commode has the height adjustment button on the front of the unit - when her mother would go to transfer herself from her wheelchair to the commode, she thinks the wheelchair is hitting the button, and when she sat on the commode, the leg fell because the pin was not protruding all the way through the hole.The user (initial reporter's mother) fell and busted the skin right above her eye.The user was already going to the doctor for her appointment, and he checked her eye, and she is okay.The user's daughter (initial reporter) states that her mother (user) has been mentally off since this incident, but also has a host of medical problems, so she is not sure that the fall contributes to her being "off." the initial reporter also states that the commode is used over their original toilet, so it is a small space for someone in a wheelchair to have to transfer from the chair to the toilet.The user is reported as having not been supervised or assisted at the time of the malfunction.The event is reported as having occurred on a tile surface.Regular weekly maintenance is reported as having occurred on the device.The device involved with this event was returned to compass health brands and inspected on 8/23/2017.The customer's complaint could not be duplicated from a review of the returned device.The returned commode was found to be assembled properly.The height adjustment holes were able to be installed inward on the unit.The pins that hold the legs onto the frame were found to be both facing inwards and outwards (two pins for each leg).There was one pin on the outward on the unit that could have been pushed in - but there is another pin on the back of the device that should have prevented the leg from sliding up, even with the front pin having been pushed in.Again, the customer's complaint could not be duplicated from a review of the returned device.

• Brand Name: CAREX
• Type of Device: DELUXE FOLDING COMMODE
• MDR Report Key: 6863356
• MDR Text Key: 86083669
• Report Number: 3012316249-2017-00116
• Device Sequence Number: 1
• Product Code: ILS
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGB34100 0000
• Device Catalogue Number: B341-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2017
• Distributor Facility Aware Date: 08/17/2017
• 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: 90 YR
• Patient Weight: 91