MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	10257BL-1
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848)
Date of Event	08/17/2021
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.It is six years old.We are filing this report in an overabundance of caution and to be timely.A follow-up report will be submitted when additional information is acquired.Initial report stated that end-user was sitting on his device and the seating pad broke.He fell on the cement and we had to take him to the er.Subsequent report stated that the end-user was sitting on the device in his yard.He reported that the brakes suddenly failed and his device spun around multiple times.He fell to the pavement and was taken to the emergency room.X-rays detected no broken bone.He was scraped up and given tylenol for the pain.His caregiver stated that he is in physical and occupational therapy and requires a nurse attendant.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12465102
• Report Number: 2438477-2021-00044
• Device Sequence Number: 11073846
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• Combination Product (Y/N): N
• 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: 10257BL-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2021
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 09/20/2021
• 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: Required Intervention
• Patient Weight: 57
• Date Report Sent to FDA: 09/13/2021