MAUDE Adverse Event Report: DANYANG JUMAO DRIVE; MANUAL WHEELCHAIR

Model Number	SSP218DDA-SF
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Contusion (1787); Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	09/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.End-user will not provide pms team with device until settlement is reached.The serial number he provided is not in our system.In an overabundance of caution we are filing this medwatch report.End-user was sitting at the table eating when the seat reportedly dropped through the frame.He advised that some of the upholstery screws were not properly threaded through the frame.He fell and suffered contusions and lacerations.He visited the doctor and was diagnosed with a fracture of the 11th vertebrae.

• Brand Name: DRIVE
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): DANYANG JUMAO; 36 danyan road,; danyang city; jiangsu provence, jiangsu 21230 0; CH 212300
• MDR Report Key: 7958413
• Report Number: 2438477-2018-00052
• Device Sequence Number: 1387224
• Product Code: IOR
• UDI-Device Identifier: 00822383140469
• UDI-Public: 822383140469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2018
• Report Date (Section F): 10/11/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SSP218DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2018
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2018
• 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 Age: 88 YR
• Patient Weight: 86
• Date Report Sent to FDA: 10/11/2018