MAUDE Adverse Event Report: INVACARE TAYLOR STREET ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL

Model Number 65100

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The device was returned for evaluation, and subsequent testing verified the complaint.The tubing is broken near the right rear at the center hole.It was also noted that the lot number has worn off.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Main frame, side, crossbar attached to rear, stress cracked at hole.

• Brand Name: ROLLITE ROLLATOR 9153637242
• 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: 5676230
• MDR Text Key: 45808077
• Report Number: 1525712-2016-01581
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/13/2012

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
• Device Model Number: 65100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2012
• Initial Date FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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