MAUDE Adverse Event Report: DRIVE; WALKER

Model Number	R800RD
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a walker.The device has not been returned for evaluation.The end-user has received lacerations when she bumps up against the side bolts on the outside of the cross frame on the rollator when her skin rips it takes a month for her legs to heal since a wound specialist must be engaged.

• Brand Name: DRIVE
• Common Device Name: WALKER
• MDR Report Key: 12463065
• Report Number: 2438477-2021-00021
• Device Sequence Number: 1244697
• Product Code: ITJ
• UDI-Device Identifier: 00822383524115
• UDI-Public: 822383524115
• 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): 09/13/2021
• Report Date (Section F): 09/13/2021

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: R800RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2021
• Device Age: 15 MO
• Date Report to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2021
• 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: Other
• Patient Weight: 55
• Date Report Sent to FDA: 09/13/2021