MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; ROLLATOR

Model Number	10215BL-1
Medical Device Problem Codes	Component Missing (2306); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user who stated that "three of the wheels broke off after hitting a pothole in the street and they sustained a swollen leg and scratches." the end user was taken to the emergency room to treat her injuries.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): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 16643218
• Report Number: 2438477-2023-00020
• Device Sequence Number: 14790668
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/30/2023
• Report Date (Section F): 03/30/2023

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: 10215BL-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2023
• Device Age: 4 MO
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2023
• 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 Age: 54 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/30/2023