MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE; ROLLATOR

Model Number	146-R726BL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a rollator by a provider, who stated that "the walker was too large for the patient and she fell using it.Was allegedly injured and hospitalized." there were no details on the type or severity of the injury within the initial complaint.Drive is continuing to try to contact the end user for additional information and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; no 1 chuangye st sw industrial; matou ecological industry park; handan city, hebei 05604 6; CH 056046
• MDR Report Key: 16847521
• Report Number: 2438477-2023-00042
• Device Sequence Number: 18033991
• Product Code: ITJ
• UDI-Device Identifier: 00612479223103
• UDI-Public: 00612479223103
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2023
• Report Date (Section F): 05/01/2023

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: 146-R726BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Date Report to Manufacturer: 05/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• 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: Unknown
• Date Report Sent to FDA: 05/01/2023