MAUDE Adverse Event Report: AMG MEDICAL INC. HUGO; AQUA OFFSET CANE

Model Number 731-859

Device Problem Break (1069)

Patient Problems Fall (1848); Loss of consciousness (2418)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

We did not receive more information regarding the cane.We asked the customer to send us pictures of the broken cane but never received any pictures.An investigation could not be done on the unit since it was never sent to our head office.This is considered an isolated occurrence until we receive further information.A final report will be submitted once we receive more information.

Event Description

The customer walked about 10 steps from her bedroom to her bathroom using the cane.In the bathroom, the cane snapped/broke and caused the customer to fall and hit her head knocking her unconscious.Some time later, she was found unconscious and taken to the hospital via ambulance.

• Brand Name: HUGO
• Type of Device: AQUA OFFSET CANE
• 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, H4T1V-5 ; CA H4T1V5
• MDR Report Key: 7379500
• MDR Text Key: 103777954
• Report Number: 8022077-2018-00110
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/28/2018

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?: No
• Device Operator: No Information
• Device Model Number: 731-859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 53