MAUDE Adverse Event Report: DRIVEMEDICAL DRIVE MEDICAL; STEEL DROP ARM BEDSIDE COMMODE WITH PADDED SEAT & ARMS

Device Problems Collapse (1099); Material Integrity Problem (2978); No Fail-Safe Mechanism (2990); Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

On (b)(6) /2014, i ordered a handicap commode for my disabled husband which featured arms that could be lowered to facilitate sliding on and off the commode from the bed.When it arrived on (b)(6) 2014 there were warning stickers on the arms that warned against putting any weight on the arms because they would collapse without warning.This was not disclosed at the time of purchase.This commode looks like many others; like a chair with arms,.Most people would assume the arms could be used to assist in lowering/raising the body from the commode.However, because of the drop arm feature, the latch that holds the arms up is flimsy and will bend or break if much weight were to be put on them.This is a handicap bedside commode, made for people who are not able to use a regular toilet.Some of them would obviously have weak legs and would need to use the arm.When the arms do collapse unexpectedly, the person can suffer serious injury or fall off the side of the commode.In my opinion this is an exceptionally dangerous item and is more dangerous because it is marketed to handicapped people.The warning about the collapsing arms was not on the website at the time of shopping and was not verbally given when the order was taken by phone.Additionally the items is not returnable due to health laws.This warning needs to be displayed prominently on the website and the consumer should be made aware of this danger, possibly by signing a waiver.The consumers of this product are disabled, handicapped, mentally and physically compromised individuals.Most have used commodes before and would have no reason to believe the these arms could not be used like any other chair on bedside commode.Although i didn't order it from (b)(6), there are two reviewers who also say it is a dangerous item and that they were injured by the collapsing arms: (b)(6).I still have the product in my possession = yes.(b)(4).

• Brand Name: DRIVE MEDICAL
• Type of Device: STEEL DROP ARM BEDSIDE COMMODE WITH PADDED SEAT & ARMS
• Manufacturer (Section D): DRIVEMEDICAL
• MDR Report Key: 4270812
• MDR Text Key: 5009988
• Report Number: MW5039204
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Age: 72 YR