MAUDE Adverse Event Report: JIANGSU JUMAO X CARE MEDICAL EQUIPMENT DRIVE; WHEELCHAIR

Model Number	CX420ADDA-SF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a wheelchair.(b)(6) has not received the unit back for evaluation.If we receive the unit back we will file a follow-up submission.The wheelchair was in use when a bolt came loose from its nut.The wheel came lose.The end-user fell.It is reported that the end-user sustained serious and permanent injuries "including, but not limited to, brain trauma resulting in multiple seizures and brain surgery.".

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X CARE MEDICAL EQUIPMENT; no 36 danyang rd; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 10659813
• Report Number: 2438477-2020-00048
• Device Sequence Number: 11454939
• Product Code: IOR
• UDI-Device Identifier: 00822383528366
• UDI-Public: 822383528366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020
• Report Date (Section F): 10/09/2020

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: CX420ADDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2020
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2020
• 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
• Date Report Sent to FDA: 10/09/2020