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

Model Number	SSP216DDA-EL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a transport chair.The device has not been returned for evaluation.We are awaiting additional datasets as well.We are filing this report in an overabundance of caution.We will file a follow-up when additional information is available.The specific nature of the product issue is unknown.The user reportedly acquired an injury to the spine that needed treatment.The specific type of treatment is unknown at this time.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; no.36 danyan road; danyang 21230 0; CH 212300
• MDR Report Key: 11705920
• Report Number: 2438477-2021-00012
• Device Sequence Number: 3894513
• Product Code: IOR
• UDI-Device Identifier: 00822383140421
• UDI-Public: 822383140421
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021
• Report Date (Section F): 04/19/2021

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: SSP216DDA-EL
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2021
• 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
• Date Report Sent to FDA: 04/19/2021