MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number	10244-4
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive deilbiss healthcare is the initial importer of the device which is a walker.We have received photos of the damaged device.End-user is not returning the device for evaluation.Spouse reported that walker dispensed to patient failed as one of the legs on the walker bent;.Patient fell hitting his head resulting in bleeding the following data is from notes from physical therapy associate with assessment initial visit on when walker received.Patient is homebound with poor endurance and sob with minimal activity, gait is limited to household distances.Patient identified as high risk to fall environment described as cluttered, pets poorly controlled, slip hazards present.Patient very unsafe with rolling walker.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10119546
• Report Number: 2438477-2020-00033
• Device Sequence Number: 16682454
• Product Code: ITJ
• UDI-Device Identifier: 50822383515620
• UDI-Public: 50822383515620
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2020
• Report Date (Section F): 06/04/2020

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: 10244-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2020
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2020
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 71
• Date Report Sent to FDA: 06/04/2020