MAUDE Adverse Event Report: MEDLINE INDUSTRIES DROP ARM COMMODE CHAIR MODEL; ATTACHMENT, COMMODE, WHEELCHAIR

Model Number MDS89668

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Multiple Fractures (4519)

Event Date 07/10/2020

Event Type  Injury  

Event Description

Broke leg and hip; introduction: my name is (b)(6).I live in (b)(6).I am retired and have been since becoming paraplegic 22 years ago.I have successfully transferred onto and off of a commode chair like the one in the photo for most of this time.A commode chair is both a toilet and a surface to use for me to take a shower.On (b)(6) 2020 while transferring from the shower bench onto the commode chair, the right drop-arm failed to securely lock into place and i fell breaking both bones in my left leg.I weigh about (b)(6) lbs.The weight rating is 250 lbs.The unit is made by (b)(4), model number mds89668 and is from lot number 108 9010012.Every transfer is completed as a 90 degree rotation with one hand on each surface and require a couple of small hops.Detailed description: the drop-arm on the commode chair should be snug enough in the rear where it attaches to the frame so that when the handle is raised the latch meets the frame in the center and the edges of the latch land on the pins designed to hold the handle up.The image attached shows how the drop-arm has too much sway and can be brought up so that the arm is off center and comes to rest on the outside pin.To take a shower, there are two transfers.The first transfer is from my wheelchair to the commode chair.The drop-arm in question is down for the transfer then brought up after i'm on the commode chair.The day i fell, when i brought the handle up into position it came to rest in the outside position but i couldn't see the pin area because i lay a towel over the seat, and it covers the pins while still allowing for the drop-arm to raise and lock into place.I don't pay much attention to this normal operation.When i transfer onto the commode chair i put my hands on the wheelchair and the commode chair.The second transfer is into the shower.For this move i lower the left drop-arm.When i transfer onto the shower bench i put my hands on the commode seat and the shower bench.After my shower i complete the first of two hops of my transfer onto the commode chair.Then for the other half i reach to the far drop-arm and use it to complete the transfer.As i put weight on that arm it slipped off the pin and as my weight was on my right arm, when the drop-arm went down so did i.It's a physics issue.Gravity always wins.If the drop-arm had been securely fastened, it would've supported my weight as it always has.Fda safety report id# (b)(4).

• Brand Name: DROP ARM COMMODE CHAIR MODEL
• Type of Device: ATTACHMENT, COMMODE, WHEELCHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES
• MDR Report Key: 10619377
• MDR Text Key: 209811380
• Report Number: MW5097021
• Device Sequence Number: 1
• Product Code: INB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDS89668
• Device Lot Number: 108 9010012
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 77