MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; WALKER

Model Number 10240-1

Device Problem Material Deformation (2976)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 07/14/2022

Event Type  malfunction  

Event 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
• Type of Device: WALKER
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 15420134
• MDR Text Key: 299885952
• Report Number: 2438477-2022-00074
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 00822383119427
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 09/14/2022
• Distributor Facility Aware Date: 07/20/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG