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

Model Number 10266CF

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Date 06/18/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an overabundance of caution sue to a mdr regression analysis.The end-user was on the steps of a swimming pool while sitting on the device.The right front wheel reportedly fell off causing him to hit his head.He received minor abrasions as well.The device was received for evaluation.It showed normal usage.The brakes on each side were conforming.The front left wheel was detached from the unit.The front axle bolt was delivered with no damaged and signs of stripped threads.The threads inside the fork, however, show minimal damage to the threads.The root cause may be attributed to these damage threads from assembly, causing the axle bolt to detach from the unit during vibrations over time.The unit is defective historical data for complaints of the same nature was reviewed and found very limited reporting which shows no trend.

• Brand Name: DRIVE NITRO
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong
• MDR Report Key: 10146400
• MDR Text Key: 196104983
• Report Number: 2438477-2018-00068
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2020

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: 10266CF
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2020
• Distributor Facility Aware Date: 06/18/2018
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 101