MAUDE Adverse Event Report: AMG MEDICAL INC. HUGO; HUGO QUADPOD ULTRA STABLE CANE TIP

Model Number 781-030

Device Problems Break (1069); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

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.

• Brand Name: HUGO
• Type of Device: HUGO QUADPOD ULTRA STABLE CANE TIP
• Manufacturer (Section D): AMG MEDICAL INC.; 8505 dalton; montreal, quebec H4T1V 5; CA H4T1V5
• Manufacturer (Section G): AMG MEDICAL INC.; 8505 dalton; montreal, quebec H4T1V 5; CA H4T1V5
• Manufacturer Contact: katia topalian ; 8505 dalton; montreal, quebec H4T1V-5 ; CA H4T1V5 ; 7375251
• MDR Report Key: 5984578
• MDR Text Key: 56349540
• Report Number: 8022077-2016-00063
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 781-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 77