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

Model Number 700-959

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Laceration(s) (1946); Injury (2348)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

Customer fell on the rolling walker and scrapped her knee on the brake.There was no indication that the fall was due to the product malfunctioning.We received pictures illustrating that the unit was not broken.This case is now closed and no further action will be taken.

Event Description

Customer was walking using the rolling walker when she fell on the walker and scrapped her knee on the brake.She was taken to the hospital since the cut was deep.There was no indication of a product defect and the product did not contribute to the fall.

• Brand Name: HUGO
• Type of Device: HUGO ELITE ROLLING WALKER
• 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: 6130336
• MDR Text Key: 60991421
• Report Number: 8022077-2016-00127
• 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: 11/28/2016

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: 11/22/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 89 YR