MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL DRIVE DEVILBISS HEALTHCARE; WHEELCHAIR, MECHANICAL

Model Number	STD28ECDDA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of an incident involving a wheelchair by the end user who reported that the brakes did not lock when the end user went to sit down on the device.The end user slid down off the chair and caught her right leg under the cabinet which then twisted causing her to fracture her fibula and ankle.The end user had a cast for 16 weeks.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL; no.36, danyan road; yanling town; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 19787012
• Report Number: 2438477-2024-00037
• Device Sequence Number: 20939760
• Product Code: IOR
• UDI-Device Identifier: 00822383137247
• UDI-Public: 00822383137247
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/19/2024
• Report Date (Section F): 07/19/2024

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: STD28ECDDA
• Device Catalogue Number: STD28ECDDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2024
• Event Location: Home
• Date Report to Manufacturer: 07/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2024
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/19/2024