MAUDE Adverse Event Report: INVACARE TAYLOR STREET DUAL RELEASE JR. WALKER 9153629375; WALKER, MECHANICAL

Model Number 6291-JR

Device Problems Mechanical Problem (1384); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

The consumer states he was given this walker and the tips are so worn that they are down to the metal.He is on a fixed income and cannot afford to replace them.

Manufacturer Narrative

Follow up to be sent if additional information is received.

• Brand Name: DUAL RELEASE JR. WALKER 9153629375
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4817531
• MDR Text Key: 5929384
• Report Number: 1525712-2015-03301
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6291-JR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other