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

Model Number	R726RD
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user who stated that they were "outside smoking sitting on rollator and went to stand up and the unit folded on them causing him to fall onto the rollator and bent the frame." the end user was injured on his elbow and went to the doctor for medical treatment.Drive made several attempts to retrieve the product for evaluation.Drive will continue to monitor complaints for any related trends.

• 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: 16861014
• Report Number: 2438477-2022-00147
• Device Sequence Number: 5805873
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/03/2023
• Report Date (Section F): 05/03/2023

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: R726RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Date Report Sent to FDA: 05/03/2023