inforMED
MalfunctionINP

HUGO

Received Sep 28, 2016

Report 8022077-2016-00063 · MDR key 5984578

Device

Generic name

Hugo Quadpod Ultra Stable Cane Tip

Manufacturer

Amg Medical Inc.

Model number

781-030

Product problems

  • Break
  • Split

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

WE VERIFIED AND TESTED OUR STOCK AND DID NOT SEE ANY CRACKS. WE WILL MONITOR THIS CLOSELY BUT FOR NOW THIS IS AN ISOLATED OCCURRENCE. THE CUSTOMER DID NOT FALL AND THERE WAS NO INJURY. THIS CASE IS NOW CLOSED.

Description of Event or Problem

CUSTOMER PURCHASED 2 QUAD PODS AND THEY BROKE A FEW WEEKS LATER.WE SENT THE CUSTOMER NEW QUAD POD TIPS AND THE NEW ONES ALSO STARTED TO FAIL, ONE SIDE IS BROKEN AND IS SPLITTING AWAY AT THE CENTRAL SHAFT. THE CUSTOMER DID NOT FALL AND THERE WAS NO INJURY.