MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD. DRIVE; WALKER

Model Number	10109
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	10/22/2018
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.We have not received the unit back for evaluation since the incident was caused by user error.Initial damage to the device occurred in 2015 the device was used after damage.The device was initially damaged in an incident on 2015 caused by the end-user's medical condition.The end-user continued to use the device after multiple incidents on which he suffered minor injuries.In this incident the end-user fell, was taken to the emergency room by ambulance and treated for a gash on the head.At the time of this incident the device was 8 years old.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD.; yi he civil affairs industrial; guongdong 51602 3; CH 516023
• MDR Report Key: 11350062
• Report Number: 2438477-2018-00097
• Device Sequence Number: 11608972
• Product Code: ITJ
• UDI-Device Identifier: 00822383100159
• UDI-Public: 822383100159
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/19/2021
• Report Date (Section F): 02/19/2021

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: 10109
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2018
• Device Age: 8 YR
• Event Location: Home
• Date Report to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 02/19/2021