MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT CO., LTD DRIVE; WALKER

Model Number	796
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a rollator.Pms team is attempting to obtain the return of the device for evaluation.The consumer advised that she did not have the device on hand.Follow-up submission will be filed if device is retrieved and evaluated.The turn radius limiter reportedly of the device broke while in use.The end-user sustained a gash on left knee which required 10 stitches.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT CO., LTD; danyang lianhu; industrial park; danyang city,, jiangsu 21230 0; CH 212300
• MDR Report Key: 7709775
• Report Number: 2438477-2018-00038
• Device Sequence Number: 16789328
• Product Code: ITJ
• UDI-Device Identifier: 50822383509346
• UDI-Public: 50822383509346
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018
• Report Date (Section F): 07/23/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2018
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 54
• Date Report Sent to FDA: 07/23/2018