MAUDE Adverse Event Report: DRIVE; WALKER

Model Number	796
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Easy Bruising (4558)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) healthcare is the initial importer of the device which is a walker.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow-up when additional information is available.While in use the steering limiter piece of metal broke off.The user sustained an injury to her knee.An x-ray was performed with no fractures diagnosed.The diagnosis was just bruising.We are awaiting more information.

• Brand Name: DRIVE
• Common Device Name: WALKER
• MDR Report Key: 12697501
• Report Number: 2438477-2021-00062
• Device Sequence Number: 17070377
• Product Code: ITJ
• UDI-Device Identifier: 50822383509346
• UDI-Public: 50822383509346
• Combination Product (Y/N): N
• 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): 10/26/2021
• Report Date (Section F): 10/26/2021

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: 796
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2021
• Device Age: 40 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 10/26/2021