MAUDE Adverse Event Report: AMG MEDICAL INC. HUGO; HUGO QUADPOD

Model Number 781-030

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

As the hugo brand is now owned by drive medical, they were the ones that were made aware of the incident.They received a lawyer's letter and forwarded it to a.M.G.Medical inc.On march 3, 2017.Little information on the previous health and condition of the customer is mentioned.The location of the incident is unknown.Our insurance company will be in contact with the patient's lawyer so that the missing information can be obtained.

Event Description

Customer was using hugo quadpod cane when the handle suddenly slipped, causing him to fall and suffer injuries.

• Brand Name: HUGO
• Type of Device: HUGO QUADPOD
• Manufacturer (Section D): AMG MEDICAL INC.; 8505 dalton; montreal, H4T1V 5; CA H4T1V5
• Manufacturer (Section G): AMG MEDICAL INC.; 8505 dalton; montreal, H4T1V 5; CA H4T1V5
• Manufacturer Contact: katia topalian ; 8505 dalton; montreal, quebec H4T1V-5 ; CA H4T1V5 ; 7375251
• MDR Report Key: 6383720
• MDR Text Key: 69255240
• Report Number: 8022077-2017-00047
• Device Sequence Number: 1
• Product Code: KHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/07/2017

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: Lay User/Patient
• Device Model Number: 781-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1