MAUDE Adverse Event Report: CC HSING COMPANY LIMITED AMG / HUGO; WALKER

Model Number	700-959E
Health Effect - Clinical Codes	Fall (1848); Hearing Loss (1882); Hip Fracture (2349)
Date of Event	04/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the year of 2016, our oversea customer sent one unit of 700-959e for sgs testing.The sample passed the sgs testing.Since that, we didn't change the rollator design.During the past three years, we didn't hear complaints or service requests for the same product.As we didn't have any photo for showing the failure area or sent any defective unit back to our factory for investigation, we cannot provide the corrective actions.
Event or Problem Description
(b)(4) 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 end user 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): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi - di 62348 ; TW 62348
• MDR Report Key: 7973963
• Report Number: 3014273557-2018-00001
• Device Sequence Number: 11156159
• 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: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 700-959E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2018
• Initial Report FDA Received Date: 10/17/2018
• 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