MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; COMMODE

Model Number	11148CE-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	12/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a folding commode.The commode has not been returned for evaluation.An adverse event has occured without product issue.End-user was transferring from wheelchair to commode when the commode tipped.The end-user fell and hit his head.No stitches required.There was brusing of his stump.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; 6 tongxing east rd; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 10063331
• Report Number: 2438477-2020-00027
• Device Sequence Number: 3610820
• Product Code: ILS
• UDI-Device Identifier: 50822383901287
• UDI-Public: 50822383901287
• 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): 05/15/2020
• Report Date (Section F): 05/15/2020

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: Lay User/Patient
• Device Model Number: 11148CE-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2020
• 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: Other
• Patient Age: 36 YR
• Patient Weight: 79
• Date Report Sent to FDA: 05/15/2020