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

Model Number	K320DFA-ELR
Medical Device Problem Codes	Material Fragmentation (1261); Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device has not been returned for evaluation.We are filing this report in an overabundance of caution to meet reporting deadlines we will file a follow-up when additional data becomes available.While using the device the end-user was rolling down the hill.The device hits a little bump, and the side of the wheelchair by his hips cracked.He sustained a slash at the top of his arm.The end-user lives in a rehab center.

• Brand Name: DRIVE
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; no 36 danyan road; danyang 21230 0; CH 212300
• MDR Report Key: 11329753
• Report Number: 2438477-2021-00005
• Device Sequence Number: 1112363
• Product Code: IOR
• UDI-Device Identifier: 00822383133904
• UDI-Public: 822383133904
• 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): 02/15/2021
• Report Date (Section F): 02/15/2021

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: K320DFA-ELR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Device Age: 22 MO
• Event Location: Other
• Date Report to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/15/2021