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

Model Number 65650R

Device Problem Crack (1135)

Patient Problem Sprain (2083)

Event Date 09/15/2014

Event Type  No Answer Provided  

Event Description

End users spouse reported that a weld cracked on the right side of the front crossbar when sitting down.User almost fell but did twist her right knee from bracing herself.No medical attention.Just sore.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4126067
• MDR Text Key: 18289344
• Report Number: 1531186-2014-04530
• 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: 09/29/2014,09/16/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65650R
• 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: 09/29/2014
• Distributor Facility Aware Date: 09/16/2014
• Date Report to Manufacturer: 09/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 88