MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number	R726RD
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by a blind end user's caregiver, who reported that "the end user needs to be led by the handle on the rollator." the incident occurred when, while going up two steps to a landing, the wheel came off the device, causing the end user to stumble and fall over the caregiver, who was guiding her.Both were injured in the fall.The end user injured her back and the caregiver injured her shoulder and hip.They have both sought medical attention and were prescribed physical therapy.Both reportedly continue to have shoulder pain.Drive is currently investigating the incident, including attempting to retrieve the product and evaluate it.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; west of tanjialing rd; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 14978102
• Report Number: 2438477-2022-00041
• Device Sequence Number: 20108596
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2022
• Report Date (Section F): 07/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: R726RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/03/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Date Report Sent to FDA: 07/11/2022