MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number	R728BL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.Our post market team was notified of the event through a legal letter.We have no access to the device for evaluation.We are filing this report in an overabundance of caution in order to be timely.A follow-up will be submitted when additional information becomes available.At the time of the incident, the enduser was utilizing her r728bl walker.The back left wheel reportedly become dislodged from the axle.Consequently,she lost her balance and fell to the ground.The extent of the injuries are unknown.Pre-existing conditions are unknown.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10141007
• Report Number: 2438477-2020-00034
• Device Sequence Number: 11323024
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020
• Report Date (Section F): 06/10/2020

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: R728BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2020
• 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
• Date Report Sent to FDA: 06/10/2020