MAUDE Adverse Event Report: HL CORP DRIVE MEDICAL; WALKER, MECHANICAL

Model Number 10215RD-1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 11/21/2016

Event Type  Injury  

Event Description

Drive devilbiss healthcare received notice about this claim from a law firm, involving a rollator, a product imported and distributed by (b)(6).While the enduser was using the rollator, the brake cables allegedly snapped, which made the enduser unable to stop the rollator.The rollator continued down the sidewalk and eventually toppled over the enduser.The enduser fell on his back and head and allegedly sustained serious injuries.Details of the injuries has not been disclosed by the law firm as of yet.This report is based on the information that was provided by the law firm.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): HL CORP; the 3rd industrial pk; song gang town; baoan district, guangdong 51810 5; CH 518105
• MDR Report Key: 6186179
• MDR Text Key: 62742280
• Report Number: 2438477-2016-00064
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/19/2016,11/21/2016

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: 10215RD-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2016
• Distributor Facility Aware Date: 11/21/2016
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 12/19/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 136