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

Model Number RTL10266BK-T

Device Problem Solder Joint Fracture (2324)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an over abundance of caution.A follow-up will be filed when more information is available.While in use the rollator collapsed.As a result of the fall the end-user hit his head and his legs and arms were bruised.Currently the end-user cannot locate the defective unit but has agreed to send the unit back if located.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO. LTD; 3 shenghui south road; nantou town, guangdong, zhongshan city ; CH
• MDR Report Key: 11766907
• MDR Text Key: 264300777
• Report Number: 2438477-2021-00016
• 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: 05/03/2021

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: 05/03/2021
• Distributor Facility Aware Date: 04/20/2021
• Device Age: 20 MO
• Date Report to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 91