MAUDE Adverse Event Report: UNKNOWN MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 6240-A

Device Problems Misassembled (1398); Unstable (1667)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  No Answer Provided  

Event Description

End users spouse reported that the hospital put the caster wheels on the inside instead of the outside of the 6240-a walker which caused the unit to tip sideways, from being unstable, and slide out from under his wife.User fell and sustained a broken wrist.User was seen by a doctor in the emergency room and they put her wrist in a cast.Spouse stated that the device is great and works fine, all he had to do was change the caster wheels to be on the outside like our pictures show.No malfunction of the product, was assembled wrong.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4192052
• MDR Text Key: 4980363
• Report Number: 1531186-2014-05000
• 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: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/22/2014,10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6240-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2014
• Distributor Facility Aware Date: 10/17/2014
• Date Report to Manufacturer: 10/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention