MAUDE Adverse Event Report: MAXHEALTH CORP. STEP N REST ROLLATOR

Model Number FGA22300 0000

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2016

Event Type  Injury  

Event Description

The end-user was pushing the rollator with in his garage, and tried to lock the brakes - the brakes did not lock, and the end-user fell on the ground.He has a 3-inch gash on his head.No medical treatment was sought after, but his "neight" is a registered nurse and looked at his head.The returned device was evaluated on 11/17/2016 by compass health brands - the rollator's left brake cable was found to be frayed and not fully engaged when depressed, it also does not engage in the lock position; the right brake does not fully engage when depressed, and does not stay engaged in the lock position.

• Brand Name: STEP N REST ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, taiwan 221 ; TW 221
• MDR Report Key: 6113091
• MDR Text Key: 60357782
• Report Number: 3005182235-2016-00041
• 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: Patient
• Type of Report: Initial
• Report Date: 11/15/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22300 0000
• Device Catalogue Number: A223-00
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2016
• Distributor Facility Aware Date: 10/21/2016
• Event Location: Other
• Date Report to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84