MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number	RTL10266CF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Concussion (2192)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.This report is being filed as part of an mdr regression analysis.End-user was walking her dog with the device.She reported that she was leaning on the left hand side of the device and the frame near the handle bars gave way.She fell to the ground, was unconscious, and broke her nose.She was taken to the hospital by ambulance.She was diagnosed with a concussion and a bruised nose.The unit was returned and evaluated and classified as defective : defective: a product that after use shows an inability to meet its intended design functionality due to a determined factor.The break was on the left frame not the handle.There was a confirmed defect on the left side of the frame.However, the defect did not go through to the other side of the frame nor did it cause the frame to fall apart.This may have been due to a horizontal force placed on the unit, causing stress and the unit to crack.There is a baggage claim tag on the unit for flight dl 0574 as well as a wire on the backrest adjustment knob.Historical data on complaint shows that this was an isolated incident.Root cause cannot be determined.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui south rd; nantoou town; zhongshan city, guangdong ; CH
• MDR Report Key: 10630658
• Report Number: 2438477-2018-00071
• Device Sequence Number: 3649384
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2020
• Report Date (Section F): 10/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266CF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2018
• Device Age: 14 MO
• Event Location: Other
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• 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: Other
• Patient Age: 86 YR
• Patient Weight: 90
• Date Report Sent to FDA: 10/05/2020