MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	RTL10266DT
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will submit a follow up when additional information is available.The end-user walked into the motionless device on the jetway.She gauged her leg about 6 inches long.An ambulance came to take her to the er.The er doctor was unable to completely sew up the injury.He gave her 4 stitches and instructed her not to get it wet.She was sent to a wound care specialist who added additional stitches to the wound.He defined the injury as an avulsion laceration.Antibiotics were prescribed to prevent infection.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12495609
• Report Number: 2438477-2021-00045
• Device Sequence Number: 14376292
• Product Code: ITJ
• UDI-Device Identifier: 00822383972497
• UDI-Public: 822383972497
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/20/2021
• Report Date (Section F): 09/20/2021

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: RTL10266DT
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2021
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2021
• 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: Required Intervention
• Date Report Sent to FDA: 09/20/2021