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

Model Number	700-959E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.Our post market associate has been attempting to collect data regarding this incident but has been unable to reach the end-user, end-user fell off rollator and broke her hip.She is in a nursing home receiving physical therapy due to the injury.It is unknown how she fell.There is no indication of product issue.We are filing a report in an overabundance of caution.This report will be updated by followup submission when information becomes available.

• Brand Name: HUGO
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town; zhongshan city, ; CH
• MDR Report Key: 8623728
• Report Number: 2438477-2019-00026
• Device Sequence Number: 19397460
• Product Code: ITJ
• UDI-Device Identifier: 00754021210602
• UDI-Public: 754021210602
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/20/2019
• Report Date (Section F): 05/20/2019

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?: No
• 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: 03/13/2019
• Device Age: 5 MO
• Date Report to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2019
• 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: Required Intervention
• Date Report Sent to FDA: 05/20/2019