MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number HCANE-ROLL-SL

Device Problem Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/19/2019

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a rollator.We are still awaiting return of the device for evaluation.We will file a followup after evaluation has occured.The end-user was descending the stairs when the device "shifted".The user fell.She hit the left side of her face and her left knee.The left knee had undergone a knee replacement in the past.Upon investigation it was noted that a screw had come out of the device.This screw had reportedly came out of the device on a prior occasion.

Event Description

Drive devilbiss is the initial importer of the device which is a rollator.We are still awaiting return of the device for evaluation.We will file a followup after evaluation has occured.The end-user was descending the stairs when the device "shifted." the user fell.She hit the left side of her face and her left knee.The left knee had undergone a knee replacement in the past.Upon investigation it was noted that a screw had come out of the device.This screw had reportedly came out of the device on a prior occasion.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 9090240
• MDR Text Key: 162296524
• Report Number: 2438477-2019-00064
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383584775
• UDI-Public: 822383584775
• 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: 09/19/2019

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: HCANE-ROLL-SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 113