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

Model Number 510

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Date 01/09/2018

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 220499835
• Report Number: 2438477-2018-00092
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383108506
• UDI-Public: 822383108506
• 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: 12/09/2020,12/08/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 510
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2020
• Distributor Facility Aware Date: 01/11/2018
• Date Report to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 76