MAUDE Adverse Event Report: INVACARE TAYLOR STREET ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number UNKNOWN

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

"the patient says she´s been shopping with her son and when they was going home, the walker felt weird.The wheel then fell off.The patient was helped to sit down on a bench and to wait while her son went to the patient's home and took her wheelchair.The patient takes a lot of support from her walker when she is using it.In the residential area where the patient lives, there is an extensive renovation work which makes a very uneven ground.Information provided to the supplier in september 2016.The patient has been given a different model, which seems to work well." the melody is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in, (b)(6).

Event Description

"the patient says she´s been shopping with her son and when they was going home, the walker felt weird.The wheel then fell off.The patient was helped to sit down on a bench and to wait while her son went to the patient's home and took her wheelchair.The patient takes a lot of support from her walker when she is using it.In the residential area where the patient lives, there is an extensive renovation work which makes a very uneven ground.Information provided to the supplier in september 2016.The patient has been given a different model, which seems to work well." the melody is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in (b)(6).

• Brand Name: ROLLATOR 9153651315
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6105366
• MDR Text Key: 60440148
• Report Number: 1525712-2016-02743
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/03/2016

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/16/2016
• 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