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

Model Number	11101W-2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: COMMODE
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; pingguo county industrial zone; baise city, guangxi, 53140 0; CH 531400
• MDR Report Key: 10789270
• Report Number: 2438477-2018-00083
• Device Sequence Number: 1126104
• Product Code: ILS
• UDI-Device Identifier: 50822383121098
• UDI-Public: 50822383121098
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 11101W-2
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2018
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 91
• Date Report Sent to FDA: 11/04/2020