MAUDE Adverse Event Report: AMG MEDICAL INC. HUGO

Model Number 700-959/700-961

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/11/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient had a doctor's appointment.Upon conclusion of her visit, she and her son exited the building.As she was stepping off the sidewalk onto the parking lot pavement, the right vertical pole of her hugo rolling walker 4.0 snapped, causing the patient to fall.The patient suffered an injury when she broke her shoulder.The patient was rushed to the emergency room by ambulance and was required to undergo shoulder surgery.

Manufacturer Narrative

The legal letter we received by the patient's lawyer on 05/14/2015 was the initial date that amg medical inc.Was made aware of the incident.The letter lacked important information.Our insurance company is in contact with the patient's lawyer so that the missing information can be obtained.As soon as amg medical inc.Becomes aware of new information, a follow up report will be sent in.The lawyer will also advise if the unit in question can be returned to amg medical inc.For further investigation.

• Brand Name: HUGO
• Manufacturer (Section D): AMG MEDICAL INC.; 8505 dalton; montreal, quebec H4T 1V5; CA H4T 1V5
• Manufacturer Contact: 8505 dalton; montreal, quebec H4T 1-V5 ; 5147375251
• MDR Report Key: 4827896
• MDR Text Key: 5901100
• Report Number: 8022077-2015-00001
• Device Sequence Number: 1
• Product Code: FMK
• 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: Other
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 700-959/700-961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• 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; Disability