MAUDE Adverse Event Report: DRIVE MEDICAL; COMMODE SEAT W/FRAME - PORTABLE

Model Number 11114KD-PSS

Device Problem Structural Problem (2506)

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946); Physical Entrapment (2327)

Event Date 07/01/2014

Event Type  Injury  

Event Description

I purchased this chair (b)(6) 2014.It was to be used for travel purposes.My wife is paralyzed.She has to be lifted and put on the chair.(b)(6).There is an opening in the seat at the front.Due to her condition, she cannot just sit down on the chair.She has to be lifted and put on it.Because of the opening in the front one of her legs gets caught in the opening.Even if placed evenly in the chair, a leg can slide into the opening.She has been injured twice by this happening.The solution is simple - drive needs to put a small piece of tubing in front of the opening to prevent this from happening.I have never seen an open seat without protection at the front of the opening.I have contacted drive four times and i am being ignored.My wife has suffered cuts and bruises because of this design fault.

• Type of Device: COMMODE SEAT W/FRAME - PORTABLE
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 4924387
• MDR Text Key: 6012209
• Report Number: MW5044396
• Device Sequence Number: 1
• Product Code: ILS
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 11114KD-PSS
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN; NUEDEXTA; PEOBIOTIC; SHOWER CHAIR COMMODE; HOYEN LIFT ELECTRIC BED; WHEEL CHAIR; LAXATIVIE; METOPROLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 50