MAUDE Adverse Event Report: UNKNOWN ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL

Model Number 65100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

Event Description

The caller stated the left front wheel fell off the unit when her mom sat on it last fall.The caller stated her mother fell but was not injured.

• Brand Name: ROLLITE ROLLATOR 9153637242
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5864591
• MDR Text Key: 51773551
• Report Number: 1525712-2016-02566
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• 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