MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number R800KD-BL

Device Problem Fracture (1260)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 09/17/2021

Event Type  Injury  

Event 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 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
• Type of Device: ROLLATOR
• MDR Report Key: 12646428
• MDR Text Key: 276941372
• Report Number: 2438477-2021-00058
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 00822383004228
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R800KD-BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2021
• Distributor Facility Aware Date: 09/18/2021
• Device Age: 3 MO
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 91