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

Model Number	10215RD-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by the end user, who stated that "while sitting at her kitchen table on her rollator, the rear wheel broke, causing her to fall backwards onto the unit." ems transported her to the hospital, where films showed a 20% fracture to her t7 vertebrae.Drive attempted to retrieve the product for investigation, but the end user had already discarded the unit after the incident.Drive will continue to monitor for trends.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589 huashi road; huashi town; jiangyin city, jiangsu ; CH
• MDR Report Key: 17876713
• Report Number: 2438477-2023-00131
• Device Sequence Number: 7094936
• Product Code: ITJ
• UDI-Device Identifier: 00822383100654
• UDI-Public: 00822383100654
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023
• Report Date (Section F): 10/05/2023

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: 10215RD-1
• Device Catalogue Number: 10215RD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2023
• Event Location: Home
• Date Report to Manufacturer: 10/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/05/2023