MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE MEDICAL; WHEELCHAIR

Model Number	CX418ADDA-ELR
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user's husband, who stated that the end user "fell out of chair backwards and bumped her head," causing her to sustain injury for which she is receiving physical therapy.The end user's husband also reported that upon inspection at some point, the seat upholstery was ripped and chair handle was bent.The end user declined to return the product for inspection.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 15995454
• Report Number: 2438477-2022-00127
• Device Sequence Number: 14939892
• Product Code: IOR
• UDI-Device Identifier: 00822383528335
• UDI-Public: 822383528335
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 12/16/2022

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: CX418ADDA-ELR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 5 YR
• Date Report to Manufacturer: 12/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 12/16/2022