MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; WALKER

Model Number	10240-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by an end user, who stated that the leg frame snapped and resulted in a fall, which caused some bruising.The complainant was unable to specify the location of the bruising.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: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 16043030
• Report Number: 2438477-2022-00115
• Device Sequence Number: 11996087
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 00822383119427
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/23/2022
• Report Date (Section F): 12/23/2022

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2022
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 12/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/23/2022