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

Model Number	CX416ADFA-ELR
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received any similar mdr, complaints or service request for the same product over the past three years.There is no changes on the design of the item.The static load test and fatigue test reports and inspection record are shown in the attachment.
Event or Problem Description
We received the email from our customer drive, the details as below: medwatch report # 2438477-2023-00105.The medical device involved in the incident is a wheelchair, product code: ior, model number dfl19-bl.The serial number is unknown.Please refer to the medwatch report for information about the event.As of today, the product in question has not been returned to drive medical for evaluation.Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user's caretaker, who stated that the end user was transferring out of the chair and sustained a "significant leg injury" and that "it is possible this was caused by a sharp edge on the frame of the wheelchair." the end user was provided with wound care and pain medicine as a result of the incident.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): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: belinda deng ; no.36, danyan road; danyang, jiangsu 21230-0 ; CH 212300
• MDR Report Key: 17993011
• Report Number: 3014810929-2023-00003
• Device Sequence Number: 7314153
• Product Code: IOR
• UDI-Device Identifier: 00822383528311
• UDI-Public: 00822383528311
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200466D4461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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: CX416ADFA-ELR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 57 KG