MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	SSP216DDA-SF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a wheelchair by an end user's mother, who stated that her daughter "fell off of her wheelchair due to her wheel falling off while she was riding it," reportedly causing her to sustain minor scrapes, and loss of a front tooth, for which she received pain management in the hospital.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 17054443
• Report Number: 2438477-2023-00057
• Device Sequence Number: 15199819
• Product Code: IOR
• UDI-Device Identifier: 00822383145280
• UDI-Public: 00822383145280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2023
• Report Date (Section F): 06/02/2023

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: SSP216DDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2023
• Date Report to Manufacturer: 06/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 06/02/2023