MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO., LTD HUGO; ROLLATOR

Model Number	700-959E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that "the right-hand grip slipped off and caused a fall," sustaining bruising on his back.He was taken to the hospital for evaluation and was treated with pain relief medication.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: HUGO
• Common Device Name: ROLLATOR
• Manufacturer (Section D): SICHUAN AST MEDICAL EQUIPMENT CO., LTD; no.58 ,jin-peng road; c area, luxian industrial park; luzhou city, sichuan 64610 0; CH 646100
• MDR Report Key: 15995369
• Report Number: 2438477-2022-00125
• Device Sequence Number: 17629804
• Product Code: ITJ
• UDI-Device Identifier: 07540212106020
• UDI-Public: 07540212106020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2022
• Report Date (Section F): 12/13/2022

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: 700-959E
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/06/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 12/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• 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: Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 12/13/2022