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

Model Number 10289RD

Device Problem Break (1069)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 09/22/2021

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.We have not received the device for evaluation.We will submit a follow-up when additional data is available.While in use the caster broker off of the unit.The user fell and hit her head.She also acquired scrapes on her arms.She did not seek medical attention.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENTT; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 12573824
• MDR Text Key: 281351064
• Report Number: 2438477-2021-00051
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/04/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 10289RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2021
• Distributor Facility Aware Date: 09/29/2021
• Device Age: 5 MO
• Date Report to Manufacturer: 10/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1