MAUDE Adverse Event Report: TAICANG JINGQUAN METAL PRODUCTS CO., LTD CAREX; KD KNEE WALKER

Model Number FGA337C0 0000

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 06/06/2023

Event Type  Injury  

Event Description

Customer called stating that she was reaching for something and lost balance and fell.When she fell the screw that protrudes on the left side where the height adjustment bracket is underneath the seat scratched her and she needed 9 stitches on her left leg.She states she is not looking for any compensation just wanted to let us know that something should be covering that screw.

• Brand Name: CAREX
• Type of Device: KD KNEE WALKER
• Manufacturer (Section D): TAICANG JINGQUAN METAL PRODUCTS CO., LTD; no. 168 zhen-xing road; liujiaguan town; taicang jiangsu, cn 21543 3; CH 215433
• MDR Report Key: 17225404
• MDR Text Key: 318101957
• Report Number: 3012316249-2023-00023
• 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: Other
• Type of Report: Initial
• Report Date: 06/29/2023

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: FGA337C0 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Distributor Facility Aware Date: 06/09/2023
• Device Age: 22 MO
• Event Location: Home
• Date Report to Manufacturer: 06/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG