MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE; WALKER, MECHANICAL

Model Number	301PSRN
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Brain Injury (2219)
Date of Event	09/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by a provider, who stated that the rollator collapsed, causing the patient to fall.Further information regarding the type and nature of the "collapse" was not provided.The patient was reportedly hospitalized with broken bones in her back and a brain bleed.Drive devilbiss healthcare is currently investigating the incident, including attempting to retrieve the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 18085873
• Report Number: 2438477-2023-00141
• Device Sequence Number: 20765963
• Product Code: ITJ
• UDI-Device Identifier: 00822383171128
• UDI-Public: 00822383171128
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2023
• Report Date (Section F): 11/07/2023

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: 301PSRN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2023
• Event Location: Home
• Date Report to Manufacturer: 11/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 11/07/2023