MAUDE Adverse Event Report: MAXHEALTH DRIVE MEDICAL; ROLLATOR

Model Number R726GR

Device Problem Structural Problem (2506)

Patient Problem Laceration(s) (1946)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Drive medical received notice from a customer regarding an adverse incident regarding a rollator that drive medical imports and distributes.Drive medical contacted the enduser and the provider to gather more information.Enduser was getting up from his rollator when he allegedly cut his left leg on a piece of metal sticking out from the brake.This report is based on information provided by the provider and the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH; 15f-6 no. 81, hsin tai wu rd; sec. 1; hsi chih, taipei hsien taipei - district ; TW
• MDR Report Key: 4785789
• MDR Text Key: 5818969
• Report Number: 2438477-2015-00011
• 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
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/24/2015

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: R726GR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2015
• Device Age: 2 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR