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

Model Number 700-959E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 305595980
• Report Number: 2438477-2022-00125
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 07540212106020
• UDI-Public: 07540212106020
• 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: 12/13/2022,12/15/2022

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: 700-959E
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2022
• Distributor Facility Aware Date: 09/06/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 12/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG