MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD HUGO; ROLLATOR

Model Number 700-959E

Device Problem Device Tipped Over (2589)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/14/2018

Event Type  Death  

Event Description

(b)(4) is the initial importer of the device which is a rollator.(b)(4) became aware of the incident through legal notification.The device has not been evaluated.While proceeding to roll over a transition strip between two rooms and the walker subsequently tipped straight over causing the end-user to sustain significant injuries, which reportedly led to her death.

• Brand Name: HUGO
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD; 3 shenghui south road; nantou town,; zhongshan city, ; CH
• MDR Report Key: 9241453
• MDR Text Key: 163825997
• Report Number: 2438477-2019-00072
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700-959E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Distributor Facility Aware Date: 09/17/2019
• Device Age: 13 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death