MAUDE Adverse Event Report: LIFEWALKER / PROTOSTAR, INC. UPWALKER; WALKER, MECHANICAL

Device Problems Collapse (1099); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  Injury  

Event Description

The problem is with the upwalker designed by lifewalker mobility products, (b)(6).This is a walker which allows the user to stand upright and rest one's forearms on adjustable risers.The problem occurred when the tabs which secure the armrests worked open and allowed the armrests to collapse.This nearly caused me to have a bad fall.After the tabs were re-secured, they continued to work open, and the walker collapsed several more times.Fda safety report id# (b)(4).

• Brand Name: UPWALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): LIFEWALKER / PROTOSTAR, INC.
• MDR Report Key: 8935414
• MDR Text Key: 155781641
• Report Number: MW5089328
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Weight: 91