MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; ROLLATOR

Model Number	10257RD-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by a lawyer, who stated that the end user "went to sit on the unit" and "the seat broke," reportedly causing her to fall "to the floor and hit her bottom," resulting in a fractured pelvis.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: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; zhongshan city; guangdong, 528414 ; CH
• MDR Report Key: 16248705
• Report Number: 2438477-2022-00132
• Device Sequence Number: 20446474
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/26/2023
• Report Date (Section F): 01/26/2023

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: 10257RD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2022
• Date Report to Manufacturer: 02/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2023
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 01/26/2023