MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number R728BL

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Date 08/27/2019

Event Type  Injury  

Event 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
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10141007
• MDR Text Key: 194813049
• Report Number: 2438477-2020-00034
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R728BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2020
• Distributor Facility Aware Date: 05/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other