MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	700-959E
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident by the end user of the rollator being assembled incorrectly.The end user assembled the legs and handlebars on the incorrect side and backwards.This caused the brakes to cut her legs.The wound became infected and the doctor prescribed antibiotics.The end user was educated by drive devilbiss customer solutions on the proper installation of the legs and handlebars.The end user realized her mistake in assembly of the device.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): SICHUAN AST MEDICAL EQUIPMENT CO.,LTD; no.58, jin-peng road; c area, luxian industrial park; luzhou city, sichuan 64610 0; CH 646100
• MDR Report Key: 18210454
• Report Number: 2438477-2023-00144
• Device Sequence Number: 17753599
• Product Code: ITJ
• UDI-Device Identifier: 00754021210602
• UDI-Public: 754021210602
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2023
• Report Date (Section F): 11/27/2023

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: 700-959E
• Device Catalogue Number: 700-959E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2023
• Event Location: Home
• Date Report to Manufacturer: 11/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 11/27/2023