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

Model Number	ATC19-BK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transport chair by an end user, who reported that her son "turned over" in the chair, causing him to "prick elbow," which became infected and required surgery.The end user did not identify what caused the end user to "turn over" in the chair, or specifically whether any defect in the chair caused or contributed to the injury.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• 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: 18095603
• Report Number: 2438477-2023-00135
• Device Sequence Number: 12220176
• Product Code: IOR
• UDI-Device Identifier: 00822383133645
• UDI-Public: 00822383133645
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023
• Report Date (Section F): 11/08/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ATC19-BK
• Device Catalogue Number: ATC19-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2022
• Event Location: Home
• Date Report to Manufacturer: 11/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 11/08/2023