MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	R800BK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	09/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report received, the end user experienced "a syncopal episode due to a pre-existing cardiac condition" while using a rollator, and "slumped over." the report further states that "at that time, her leg swung around and caught a metal bar above the wheel, severely lacerating her right lower leg." the end user received treatment including debridement and a skin graft, and was left with a permanent scar.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.
Event or Problem Description
According to the report received, the end user experienced "a syncopal episode due to a pre-existing cardiac condition" while using a rollator, and "slumped over." the report further states that "[a]t that time, her leg swung around and caught [a] metal bar above the wheel, severely lacerating her right lower leg." the end user received treatment including debridement and a skin graft, and was left with a permanent scar.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13082957
• Report Number: 2438477-2021-00078
• Device Sequence Number: 14810871
• Product Code: ITJ
• UDI-Device Identifier: 00822383548579
• UDI-Public: 822383548579
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021
• Report Date (Section F): 12/21/2021

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: R800BK
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 12/23/2021
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 12/21/2021