MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	10215BL-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Muscle/Tendon Damage (4532)
Date of Event	10/08/2021
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 submit a follow-up when additional data becomes available.While in use the fork broke from the frame and the user fell.She went to the er after falling.They wrapped her leg in an ace bandage and recommended she see a specialist.She was given tylenol for the pain.She sustained an injury to er knee which was diagnosed as a possible torn tendon or meniscus.The specialist had her take an mri.She was prescribed three medications including pain meds and metropod.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12696783
• Report Number: 2438477-2021-00059
• Device Sequence Number: 3706550
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/26/2021
• Report Date (Section F): 10/26/2021

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: 10215BL-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2021
• Device Age: 2 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2021
• 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: 54 YR
• Patient Weight: 102
• Date Report Sent to FDA: 10/26/2021