DRIVE MEDICAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-18 for DRIVE MEDICAL manufactured by Drivemedical.

Event Text Entries

[5009988] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039204
MDR Report Key4270812
Date Received2014-11-18
Date of Report2014-10-16
Date of Event2014-09-25
Date Added to Maude2014-11-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDRIVE MEDICAL
Generic NameSTEEL DROP ARM BEDSIDE COMMODE WITH PADDED SEAT & ARMS
Product CodeINB
Date Received2014-11-18
Device Sequence No1
Device Event Key0
ManufacturerDRIVEMEDICAL


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-18

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