MAUDE Adverse Event Report: UNKNOWN AMG / HUGO; WALKER

Model Number	700-959E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Hip Fracture (2349)
Date of Event	04/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a rollator.The serial number format suggests that this iteration of the device was made for amg medical.Drive was informed of the event with the receipt of a legal summons.We do not anticipate being able to retrieve the unit for evaluation.The enduser was navigating through a museum using the device.He sat down to speak to the tour guide when the walker frame reportedly snapped.The user fell landing on his right hip and head.He was taken to the emergency room.He was diagnosed with a fractured hip and was immediately taken to surgery.He was treated at a specialized facility and returned home after approximately 3 months.It is reported that he suffered hearing loss from the incident.

• Brand Name: AMG / HUGO
• Common Device Name: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8059289
• Report Number: 2438477-2018-00047
• Device Sequence Number: 2879195
• Product Code: ITJ
• UDI-Device Identifier: 00754021210602
• UDI-Public: 754021210602
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2018
• Report Date (Section F): 09/14/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 700-959E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2018
• Device Age: 2 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Date Report Sent to FDA: 09/14/2018