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

Model Number	795BK
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/26/2023
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 the "seat collapsed, and he fell and injured his back." the end user did not seek any medical treatment as a result of the incident, but he reports that he is still feeling pain and taking ibuprofen.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: 16837291
• Report Number: 2438477-2023-00036
• Device Sequence Number: 15340392
• Product Code: ITJ
• UDI-Device Identifier: 00822383213491
• UDI-Public: 00822383213491
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/28/2023
• Report Date (Section F): 04/28/2023

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: 795BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/30/2023
• Device Age: 8 YR
• Event Location: Home
• Date Report to Manufacturer: 05/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 99 KG
• Date Report Sent to FDA: 04/28/2023