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

Model Number	K318DDA-ELR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a wheelchair.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The back of the chair broke while in use causing the user to fall.He hit his head and arm.No further details to the event are available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR, MANUAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; 36 danyan road; danyang, jiangsu, 21230 0; CH 212300
• MDR Report Key: 11100379
• Report Number: 2438477-2018-00095
• Device Sequence Number: 3781131
• Product Code: IOR
• UDI-Device Identifier: 00822383123363
• UDI-Public: 822383123363
• Combination Product (Y/N): N
• 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): 12/30/2020
• Report Date (Section F): 12/30/2020

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: K318DDA-ELR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/19/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 104
• Date Report Sent to FDA: 12/30/2020