MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	R800KD-BL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report tin an overabundance of caution and to be timely.We will submit a follow-up when additional data becomes available.While in use the ;eft back wheel crushed and dismantled.The user fell to the ground.It took her reputedly ten (10) minutes to get up.From the floor.She went to the hospital and nothing was broken.She requires hip and knee replacement surgery.This incident has exacerbated the existing injuries.
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report tin an overabundance of caution and to be timely.We will submit a follow-up when additional data becomes available.While in use the ;eft back wheel crushed and dismantled.The user fell to the ground.It took her reputedly ten (10) minutes to get up.From the floor.She went to the hospital and nothing was broken.She requires hip and knee replacement surgery.This incident has exacerbated the existing injuries.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12646428
• Report Number: 2438477-2021-00058
• Device Sequence Number: 1140075
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 00822383004228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/18/2021
• Report Date (Section F): 10/18/2021

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: R800KD-BL
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2021
• Device Age: 3 MO
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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: Hospitalization
• Patient Weight: 91
• Date Report Sent to FDA: 10/18/2021