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

Model Number	11148CE-4
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a commode.The device is unavailable for evaluation as it has been discarded by the end-user.A picture was supplied of the issue.We are reporting this incident in an overabundance of caution.Commode chair failed at the welds.The end-user was sitting on the toilet bowl and the weld broke.The toilet seat fell through and the end-user fell to the ground.End-user believes the fall exacerbated the injury.His knee is now swollen and achy.Due to covid medical treatment has not been sought.He had a video call with his doctor advised him to take 2 - 4 tylenol a day.He has been icing his knee.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town, zhongshan city 52841 4; CH 528414
• MDR Report Key: 11324695
• Report Number: 2438477-2021-00004
• Device Sequence Number: 3335170
• Product Code: ILS
• UDI-Device Identifier: 50822383901287
• UDI-Public: 50822383901287
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 01/22/2021
• Report Date (Section F): 02/12/2021

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/22/2021
• Device Age: 21 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 129
• Date Report Sent to FDA: 02/12/2021