MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL DRIVE; ROLLATOR

Model Number	R726BK
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.The user is refusing to return the device.We will file a follow-up submission if additional data becomes available.The end user reported that there are sharp edges on her device.A child fell into the device and received a laceration on their head which required 5 stitches.She is concerned about the sharpness since she is on blood thinners.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL; west of tanjialing road; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 12791790
• Report Number: 2438477-2021-00070
• Device Sequence Number: 14867396
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section F): 11/10/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: R726BK
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Device Age: 13 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 11/10/2021