DRIVEMEDICAL QUAD CANE TIP

Additional Manufacturer Narrative

THE QUAD CANE TIP WAS RETURNED TO DRIVE DEVILBISS HEALTHCARE FOR EVALUATION. THE PRODUCT WAS IN GOOD CONDITION IN ITS ORIGINAL PACKAGING. THE CANE TIP WAS REVIEWED ON A HARDWOOD FLOOR CONFIRMING THAT THERE IS GRIP WHEN LOAD IS APPLIED. NO DEFECTS WERE FOUND. COMPLAINTS DATA WAS REVIEWED FOR FURTHER INSIGHT ON THE CANE TIP DESIGN CUSTOMER CONCERN OF THE CANE TIP NOT GRIPPING THE FLOOR SURFACE. THIS COMPLAINT WAS THE ONLY ONE IDENTIFIED IN A TWO-YEAR TIME PERIOD. THE SUPPLIER WAS NOTIFIED OF THE COMPLAINT. THIS APPEARS TO BE AN ISOLATED INCIDENT FROM THE COMPLAINTS DATA REVIEW. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR TRENDS.

Description of Event or Problem

DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CANE TIP BY THE PROVIDER, WHO STATED THAT DURING USE ON A HARDWOOD FLOOR OF THEIR HOME, THE END USER FELL AND BROKE HER HIP, REQUIRING HOSPITALIZATION. THE PROVIDER REPORTED THAT THE BOTTOM OF THE CANE TIP DOES NOT GRIP TO THE HARD FLOOR SURFACE DURING USE. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.