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

Model Number	R728BL
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Laceration(s) (1946); Vertebral Fracture (4520)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of several incidents regarding a rollator from the end user.She stated that "the brakes have already had to be fixed 6 times and now they are unrepairable as the wires are coming out." she received a cut on her hand from a frayed cable which was treated with peroxide and a bandage.She continued to use the broken device although she noted the brakes were not functioning properly which resulted in a fall in which she fractured her l7.She has been admitted to the hospital.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.
Event or Problem Description
Drive devilbiss was notified by the end user of several incidents involving a rollator.She stated that "the brakes have already had to be fixed 6 times and now they are unrepairable as the wires are coming out." one of the reportedly frayed cables cut her hand, which she treated with peroxide and a bandage.Thereafter, while continuing to use the broken device, she fell and fractured her l7, and has been admitted to the hospital.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.We will update this report when additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINBO SHENYU MEDICAL EQUIPMENT; west of tanjialing road; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 13655984
• Report Number: 2438477-2022-00007
• Device Sequence Number: 14029527
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022
• Report Date (Section F): 03/07/2022

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: R728BL
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/24/2021
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/07/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 03/07/2022