MAUDE Adverse Event Report: HL CORP (SHENZHEN) DRIVE; ROLLATOR

Model Number	510
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We were unable to retrieve the device for evaluation.We are filing this report in an over-abundance of caution due to an mdr regression analysis.Unit handle broke while in use.End-user fell and hit his head.He was taken to the hospital.He did not have any broken bones.Historical data for complaints of the same nature were reviewed.Very limited reporting was found and showing no trend.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HL CORP (SHENZHEN); the 3rd industrial park; bitou village; song gang town, baon dist shenzhen 51810 5; CH 518105
• MDR Report Key: 10977476
• Report Number: 2438477-2018-00092
• Device Sequence Number: 4258520
• Product Code: ITJ
• UDI-Device Identifier: 00822383108506
• UDI-Public: 822383108506
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 B): 12/08/2020
• Report Date (Section F): 12/09/2020

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: 510
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/11/2018
• Date Report to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76
• Date Report Sent to FDA: 12/09/2020