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

Model Number RTL10266BK-T

Device Problem Break (1069)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.This complaint was pulled from a consumer review website and we are unable to obtain any contact information from the user.The device was not returned for evaluation.We will file a follow-up when additional information becomes available.The frame broke while the user was sitting on his front porch.He fell and hit his head.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO; 3 shenghui s road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 13009617
• MDR Text Key: 282265000
• Report Number: 2438477-2021-00076
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• 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: 12/15/2021

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: RTL10266BK-T
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2021
• Distributor Facility Aware Date: 12/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male