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

Model Number RTL10266CF

Device Problem Crack (1135)

Patient Problems Bruise/Contusion (1754); Concussion (2192)

Event Date 01/19/2018

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui south rd; nantoou town; zhongshan city, guangdong ; CH
• MDR Report Key: 10630658
• MDR Text Key: 209978065
• Report Number: 2438477-2018-00071
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266CF
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2020
• Distributor Facility Aware Date: 04/05/2018
• Device Age: 14 MO
• Event Location: Other
• Date Report to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 90