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

Model Number R728BL

Device Problem Device Damaged Prior to Use (2284)

Patient Problems Laceration(s) (1946); Vertebral Fracture (4520)

Event Date 11/04/2021

Event Type  Injury  

Event 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 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINBO SHENYU MEDICAL EQUIPMENT; west of tanjialing road; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 13655984
• MDR Text Key: 288482908
• Report Number: 2438477-2022-00007
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R728BL
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 11/24/2021
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 54 KG