MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; WALKER

Model Number	10240-1
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Fall (1848); Skin Tears (2516)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a hemi one-arm walker by the director of a nursing facility, who reported that "during a staff-assisted transfer, the leg of the walker bent mid-transfer making it unable to provide the needed support," which caused the patient to fall," sustaining a "a skin tear to their right elbow." medical attention was provided by nursing staff.Drive is attempting to have unit returned for evaluation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 15420134
• Report Number: 2438477-2022-00074
• Device Sequence Number: 2545430
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 00822383119427
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022
• Report Date (Section F): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10240-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2022
• 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: 100 KG
• Date Report Sent to FDA: 09/14/2022