MAUDE Adverse Event Report: AMG MEDICAL INC. HUGO; HUGO ELITE ROLLING WALKER WITH A SEAT

Model Number 700-959

Device Problem Break (1069)

Patient Problems Contusion (1787); Fall (1848); Bone Fracture(s) (1870)

Event Type  No Answer Provided  

Manufacturer Narrative

This unit was purchased in 2004 and has been in use for 12 years.We contacted the end-user and a replacement rolling walker was sent to his home address.This is a very old unit and we have done all sort of corrective actions on the new revisions of the rolling walker.This case is closed.

Event Description

The end-user was visiting family and walking down the street when the support leg above the wheel snapped in two and she fell to the ground.She fractured her ankle and had contusions on her arm.

• Brand Name: HUGO
• Type of Device: HUGO ELITE ROLLING WALKER WITH A SEAT
• 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: 5730617
• MDR Text Key: 47590512
• Report Number: 8022077-2016-00040
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 06/16/2016

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: 700-959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/16/2016
• Date Device Manufactured: 09/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 88