MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD DRIVE; WHEELCHAIR

Model Number	SSP220DDA-SF
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by the end users' mother, who stated "her daughter was at school this past wednesday and the chair collapsed on her while sitting in it," causing her to cut her finger.The end user did receive medical attention, the details of which are currently unknown.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.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the incorrect manufacturer name in section d3 and f14.The information has been updated in these sections to reflect the correct manufacturer name.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD; no.36 danyan road; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 15683344
• Report Number: 2438477-2022-00106
• Device Sequence Number: 17734759
• Product Code: IOR
• UDI-Device Identifier: 00822383140506
• UDI-Public: 00822383140506
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/12/2023
• Report Date (Section F): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SSP220DDA-SF
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2022
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 136 KG
• Date Report Sent to FDA: 12/12/2023