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

Model Number 700-959E

Device Problem Break (1069)

Patient Problems Fall (1848); Hearing Loss (1882); Hip Fracture (2349)

Event Date 04/28/2018

Event Type  Injury  

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 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
• Type of Device: WALKER
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi - di 62348 ; TW 62348
• Manufacturer (Section G): CC HSING COMPANY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi - di 62348 ; TW 62348
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7973963
• MDR Text Key: 123981160
• Report Number: 3014273557-2018-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754021210602
• UDI-Public: 754021210602
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 700-959E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2018
• Initial Date FDA Received: 10/17/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization