MAUDE Adverse Event Report: JAN MAO INDUSTRIAL CO., LTD DRIVE; WALKER

Model Number 10233

Device Problem Sticking (1597)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/16/2015

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a walker.(b)(4) became aware of the event by legal notification.The end-user was at a dealership using the device.When he was exiting the dealership the rear leg/brake got caught on the carpet.The end-user fell.He went to the hospital.He reportedly hurt his back.We do not have access to the product to determine root cause.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): JAN MAO INDUSTRIAL CO., LTD; pingguo county; industrial zone; baise city, guangxi 53140 0; CH 531400
• MDR Report Key: 7397521
• MDR Text Key: 104381342
• Report Number: 2438477-2018-00013
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/04/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2018
• Distributor Facility Aware Date: 06/02/2016
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 04/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other