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

Model Number	ATC19-BL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hematoma (1884)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair.The end user's daughter reported that while "i was wheeling my mother on the street, the chair broke with her in it.The metal bar holding the front wheel in place broke in half, causing the chair to collapse" beneath her.The end user "fell on the sidewalk and hit her head." the end user "suffered bruising on her head, a contusion, soft tissue swelling and hematoma on her forehead and eye and needed a ct scan." drive is currently investigating the incident, including attempting to retrieve the product and inspect it.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE; no.36 danyan rd; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 14977764
• Report Number: 2438477-2022-00033
• Device Sequence Number: 20089150
• Product Code: IOR
• UDI-Device Identifier: 00822383133621
• UDI-Public: 822383133621
• 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): 07/11/2022
• Report Date (Section F): 07/11/2022

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: ATC19-BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/11/2022
• Device Age: 21 MO
• Event Location: Other
• Date Report to Manufacturer: 05/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• 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 Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 07/11/2022