MAUDE Adverse Event Report: COM-DA HEALTHCARE DRIVE; WALKER

Model Number	10240-1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was not returned for evaluation.The device snapped while in use and he fell hitting his back and head.An ambulance was called.No further information is available.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE; unit 3 no.94 dongcheng road; dong sheng town; zhong shan city, guangdon ; CH
• MDR Report Key: 11072172
• Report Number: 2438477-2018-00094
• Device Sequence Number: 3311273
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 822383119427
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial
• Report Date (Section B): 12/24/2020
• Report Date (Section F): 12/29/2020

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: 10240-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2018
• Device Age: 6 MO
• Date Report to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1