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

Model Number	RTL10266BK-T
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2021-00016
• Device Sequence Number: 3157769
• Product Code: ITJ
• UDI-Device Identifier: 00822383523934
• UDI-Public: 822383523934
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2021
• Report Date (Section F): 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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266BK-T
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/20/2021
• Device Age: 20 MO
• Date Report to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 91
• Date Report Sent to FDA: 05/03/2021