MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD DRIVE; ROLLATOR

Model Number	10289RD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/09/2021
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 reported that "i was entering a bathroom going over a small threshold when the front wheel of my walker broke off and i fell and broke left elbow." surgery was not an option because of unrelated medical conditions.The end user reports now using ibuprofen to manage her elbow pain.Drive made multiple attempts to retrieve the unit for evaluation, with no response.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 15432067
• Report Number: 2438477-2022-00094
• Device Sequence Number: 18017955
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 00822383259338
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/15/2022
• Report Date (Section F): 09/15/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10289RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2022
• Device Age: 4 YR
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 118 KG
• Date Report Sent to FDA: 09/15/2022