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

Model Number	RTL10261RD
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that she was "sitting on unit, got up and the front right leg broke," causing her to fall "sideways and hit head on kitchen table, hit right side of head and start bleeding." the end user went to the hospital and confirmed that she did not sustain a concussion and that her ct scans were normal.She received 2 stitches and tylenol for pain.The end user reported that she is "unable" to return unit for evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu rd, huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 15075611
• Report Number: 2438477-2022-00070
• Device Sequence Number: 4784797
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2022
• Report Date (Section F): 07/21/2022

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?: No
• Device Model Number: RTL10261RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2022
• Date Report to Manufacturer: 07/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 07/21/2022