MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT CO., LTD. PROBASICS KNEE WALKER (HAMMERTONE FINISH); KNEE SCOOTER

Model Number PB1030KW

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The end-user hurt herself while using this product.She is claiming to have back problems due to getting hurt while using.She said something came unscrewed while using this device.The customer has not responded to multiple follow-up attempts to ask for more information on the user injury and the product defect.

• Brand Name: PROBASICS KNEE WALKER (HAMMERTONE FINISH)
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT CO., LTD.; danyang lianhu industrial park; danyang city, jiangsu 21230 0; CH 212300
• MDR Report Key: 6516035
• MDR Text Key: 73501108
• Report Number: 3012316249-2017-00046
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017,03/27/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: PB1030KW
• Device Catalogue Number: 1030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2017
• Distributor Facility Aware Date: 03/27/2017
• Date Report to Manufacturer: 04/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other