MAUDE Adverse Event Report: UNKNOWN ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL

Model Number UNKNOWN

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

The end user stated that she was using the unit, model number 1024blk, probasics.She stated bearings are falling free from the back left caster.She stated that she has not been injured using the unit.

• Brand Name: ROLLATOR ADULT RED 9153641186
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4442713
• MDR Text Key: 5310893
• Report Number: 1525712-2015-00601
• Device Sequence Number: 1
• Product Code: INI
• 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
• Type of Report: Initial
• Report Date: 01/12/2015

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 01/22/2015
• 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