MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	RTL10266
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will file a follow-up submission when additional information is available.While in use the bottom part bar that goes across the unit just came off causing her to topple over and roll down the hill.She received cuts on right elbows and left leg.She went to her family doctor who prescribed antibiotics when her elbow got infected.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12586111
• Report Number: 2438477-2021-00050
• Device Sequence Number: 3694871
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/04/2021
• Report Date (Section F): 10/06/2021

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: RTL10266
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2021
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2021
• 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 Age: 60 YR
• Patient Weight: 61
• Date Report Sent to FDA: 10/06/2021