MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ECONOMY ROLLATOR RED WITH HAND BRAKES AND CURVED BACKREST 9153646615; WALKER, MECHANICAL

Model Number 65650R

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Laceration(s) (1946)

Event Date 06/11/2016

Event Type  Injury  

Event Description

Customer states that one of the brake handles is working and one of them is not.One of the brakes are missing the brake pads.And the other side is half worn.Customer mentioned that the unit belongs to her father.And on (b)(6) he did fall to the floor inside the house in the laundry room off of the kitchen.Customer stated he uses the rollator all the time due to he is unstable.Customer is not aware if the fall was due to the rollator.Customer states that when she arrived to the house, she witnessed the rollator was not in the usual place it normally is.Customer presumes it was just moved out of the way for the emt's.He hit his head and received 10 stitches on his head.A hematoma over his eye.Down his left side bruising from hip down his leg.And he received a cut on his left shoulder.And he had slight bleeding on the brain.His blood pressure dropped and went into atrial fibrillation (afib).In the hospital for one week.Xray & ct scans, were given.After released went into rehab for 1 week to work on his balance and strength.Customer states that she is not 100% sure that the unit caused the accident she was not there, her father was on his own and he cannot remember what took place.Product was returned for evaluation.Manufacturer confirmed as danyang maxthai medical equipment co.The return fields in oracle state: rollators.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed.The brake pads were observed to be present and in good condition.The brakes were able to be engaged and disengaged properly.However, the right brake was unable to stop rotation of the right rear wheel when engaged.Also, the left rear wheel was observed to be bent and warped in such a way that it made contact with the fork assembly.This prevented the wheel from rotating any further.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.The user manual warns to verify operation of the brakes and have them adjusted if necessary.Contact your invacare dealer for brake adjustment.

• Brand Name: ECONOMY ROLLATOR RED WITH HAND BRAKES AND CURVED BACKREST 9153646615
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 5842764
• MDR Text Key: 51011659
• Report Number: 1531186-2016-00018
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/28/2016,07/27/2016

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: 65650R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2016
• Distributor Facility Aware Date: 07/27/2016
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 07/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 85