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

Model Number	RTL10266
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/01/2020
Event or Problem Description
Drive devilbiss healthcare is the initial reporter of the device which is a rollator.We are filing this report to correct inaccuracies in hte medwatch filing mw5096025.There was no serious injury, intervention required, or a device malfunction.The end-user lives in a senior citizen residence.While adjusting the brake the consumer pinched his pinkie.It bled and her required the nurse to assist.Treatment was application of a bandaid.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui south rd; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 10674958
• Report Number: 2438477-2020-00049
• Device Sequence Number: 14210186
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/13/2020
• Report Date (Section F): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2020
• Device Age: 11 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/13/2020