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

Model Number	700-959
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator on january 27th.The end-user was utilizing the device while exiting the bus via the steps.The end user reported that the left rear leg broke and she fell to the ground on top of the unit.She reported that she "had bruised ribs, left leg, ankle, scrapes on both hands." she explained that "paramedics were called since it happened at the bus station.They cleaned the cuts on my hands and leg.Checked for broken bones.I had bruised ribs, but not broken.I refused to go to hospital with tons of covid patients there." the end user had been using the rollator after having neck surgery due to an unrelated accident that caused her to be partially paralyzed down her left side.The device was provided to her by the previous user.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: HUGO
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; no. 2 workshop; 3 shenghui south rd.; nantou town, zhongshan city guangdong ; CH
• MDR Report Key: 13684387
• Report Number: 2438477-2022-00015
• Device Sequence Number: 5046549
• Product Code: ITJ
• UDI-Device Identifier: 00754021210886
• UDI-Public: 754021210886
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2022
• Report Date (Section F): 03/02/2022

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: 700-959
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2022
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 03/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2022
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Date Report Sent to FDA: 03/02/2022