MAUDE Adverse Event Report: DANYANG JUMAO DRIVE; MANUAL WHEELCHAIR

Model Number SSP218DDA-SF

Device Problem Material Integrity Problem (2978)

Patient Problems Contusion (1787); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/30/2018

Event Type  Injury  

Event 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
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): DANYANG JUMAO; 36 danyan road,; danyang city; jiangsu provence, jiangsu 21230 0; CH 212300
• MDR Report Key: 7958413
• MDR Text Key: 123488636
• Report Number: 2438477-2018-00052
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383140469
• UDI-Public: 822383140469
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SSP218DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2018
• Distributor Facility Aware Date: 09/30/2018
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Weight: 86