MAUDE Adverse Event Report: UNKNOWN ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number SELFCARE

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

(b)(6) is the son of the end user; his mother and father both use a green rollator, no model or lot number to reference and the seat is cracked.(b)(6) states has had unit for about 2 years.

• Brand Name: ROLLATOR 9153651315
• 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: 4751533
• MDR Text Key: 5825200
• Report Number: 1525712-2015-02878
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/15/2015

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: SELFCARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/06/2015
• 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