MAUDE Adverse Event Report: MAXHEALTH CORP. ROSCOE; E-SERIES ROLLATOR

Model Number 30167

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Fall (1848); Discomfort (2330); Injury (2348)

Event Type  Injury  

Event Description

The end-user had the rollator for less than five years.The user was walking with the rollator, and the frame broke near one of the wheels, and he fell forward.The user went to the er, and had x-rays; he had bruises all over his right side & sores, as well as chest and knee problems.He had to go to another doctor for more x-rays, and so far nothing is showing up, but he still has discomfort.This event happened in (b)(6) 2017, but it has taken about a month for him to fully function and walk again because of the discomfort.The event is reported as having occurred on a cement surface while the user was pushing the rollator.

Event Description

The device was returned for inspection and the end user's complaint was confirmed.The device shows signs of heavy use; including worn/flattened tires, ripped seat, and missing paint/scrapes on the frame.The left rear wheel (standing behind the unit) was found to still be attached to the frame, but the frame cracked right under the weld for the cross bar seat support.This breakage also caused the sub-frame to bend inwards.

• Brand Name: ROSCOE
• Type of Device: E-SERIES ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, 221 ; TW 221
• MDR Report Key: 6879888
• MDR Text Key: 86766328
• Report Number: 3012316249-2017-00121
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/29/2018,10/06/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 30167
• Device Catalogue Number: 30167
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Distributor Facility Aware Date: 08/25/2017
• Event Location: Other
• Date Report to Manufacturer: 06/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 93 YR
• Patient Weight: 98