MAUDE Adverse Event Report: ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY L DRIVE; COMMODE

Model Number	11135-1
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bariatric commode.This report is in response to a medwatch report (b)(4).The following is a verbatim account of the event from the investigation.The incident occured in a hospital.An attendant was assisting the patient to the commode.The attendant briefly left the room and heard a loud crash.Upon returning, the attendant saw the patient on the floor and the left arm of the commode bent.The patient may have briefly sat on the arm to adjust themselves and the arm bent.The attendant was also not sure if the pin in the arm was fully extended.The facility did not ask the patient any questions after the incident as he was "out of it." the patient fractured the base of his right thumb, which required surgery, and had a laceration above the left eye, which was approximately 2-3 cm in length.It is currently unknown if stitches were needed.We have requested photos of the product and will be discussing the return of the commode within our covid-19 protocols.A warning label is required on the arm of the commode.The label is 3" x 1" with a black background and yellow lettering with a warning icon.The required verbiage is "use the arm supports only for assistance.Do not attempt to use the arms to support full body weight." placement of the label is required on the arm of the commode.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): ZHONGSHAN REXON REHABILITATION EQUIPMENT COMPANY L; 56 shangye st 3 industrial pk; chenggui road wuguishan; hongshan city, guangdong province 52845 8; CH 528458
• MDR Report Key: 10538773
• Report Number: 2438477-2020-00044
• Device Sequence Number: 304715
• Product Code: ILS
• UDI-Device Identifier: 00822383102214
• UDI-Public: 822383102214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2020
• Report Date (Section F): 09/15/2020

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: Health Professional
• Device Model Number: 11135-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2020
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2020
• 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: Required Intervention
• Date Report Sent to FDA: 09/15/2020