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

Model Number ATC19-BK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Date 03/21/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 327670217
• Report Number: 2438477-2023-00135
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383133645
• UDI-Public: 00822383133645
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 11/08/2023
• Distributor Facility Aware Date: 03/21/2022
• Event Location: Home
• Date Report to Manufacturer: 11/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention