MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	10257RD-1
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.End-user purchased a secibd hand unit.End-user cut her left leg on the brake assembly while walking behind the rollator.She went to er and received stitches.A week later she was reaching for something while seated on the unit in her bathroom.She reached for something.When she pulled her leg back she caught it and began to bleed.She went to the er and received 3 stitches.The end-user is not returning the unit for evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8911762
• Report Number: 2438477-2019-00049
• Device Sequence Number: 1938025
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/06/2019
• Report Date (Section F): 08/20/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10257RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2019
• 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: 75 YR
• Patient Weight: 52
• Date Report Sent to FDA: 08/20/2019