MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO., LTD. DRIVE; COMMODE

Model Number 11101W-2

Device Problem Unintended Movement (3026)

Patient Problem Bruise/Contusion (1754)

Event Date 03/19/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a steel drop-arm commode with wheels and padded armrests.We are filing this report in an over-abundance of caution due to an mdr regression analysis.End-user was sitting in the wheeled commode in the shower.He was sitting back and then leaned forward to reach a grab bar.The commode slipped and he fell into the wall.He received a black eye, bruising on the back of his head, neck, and back.He was too embarrassed to seek medical attention.The device was not returned for evaluation.There are no historical complaints of this nature.Probable root cause is due to occupant leaning forward and not sitting all the way back on the seat.This resulted in uneven weight distribution on the unit.This will be considered an isolated incident.

• Brand Name: DRIVE
• Type of Device: COMMODE
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; pingguo county industrial zone; baise city, guangxi, 53140 0; CH 531400
• MDR Report Key: 10789270
• MDR Text Key: 214743857
• Report Number: 2438477-2018-00083
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 50822383121098
• UDI-Public: 50822383121098
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11101W-2
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2020
• Distributor Facility Aware Date: 03/19/2018
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 91