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

Model Number 700-959

Device Problem Fracture (1260)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 01/06/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 286847380
• Report Number: 2438477-2022-00015
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754021210886
• UDI-Public: 754021210886
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022,01/27/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 700-959
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Distributor Facility Aware Date: 01/27/2022
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 03/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG