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

Model Number	HCANE-ROLL-SL
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2019-00064
• Device Sequence Number: 2298509
• Product Code: ITJ
• UDI-Device Identifier: 00822383584775
• UDI-Public: 822383584775
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019
• Report Date (Section F): 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
• Operator of Device: Lay User/Patient
• Device Model Number: HCANE-ROLL-SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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 Weight: 113
• Date Report Sent to FDA: 09/19/2019