MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL DRIVE; ROLLATOR

Model Number R726BK

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 10/01/2021

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL; west of tanjialing road; yuyao, zhejiang, 31540 8; CH 315408
• MDR Report Key: 12791790
• MDR Text Key: 283141826
• Report Number: 2438477-2021-00070
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• 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
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R726BK
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Distributor Facility Aware Date: 11/10/2021
• Device Age: 13 MO
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female