MAUDE Adverse Event Report: UNKNOWN CANE, CRUTCH AND WALKER TIPS AND PADS; 890.3790

Model Number G6271

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that the glide tips are hard to roll and are sticking, making it difficult to maneuver the unknown walker.

• Brand Name: CANE, CRUTCH AND WALKER TIPS AND PADS
• Type of Device: 890.3790
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3673369
• MDR Text Key: 4344714
• Report Number: 1525712-2014-01088
• Device Sequence Number: 1
• Product Code: INP
• 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: 02/11/2014

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: Other
• Device Model Number: G6271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/11/2014
• 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