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

Model Number UNKNOWN

Device Problems Device Stops Intermittently (1599); Mechanical Jam (2983)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that the end user stated that while she was walking down the street on sidewalks that were uneven, the bearings in front wheel locked up, caused front wheel to spin and she fell forward onto the ground.End user was not injured, and she could not provide any further information.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4001602
• MDR Text Key: 22261254
• Report Number: 1525712-2014-04540
• 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
• Type of Report: Initial
• Report Date: 08/12/2014,07/09/2014

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2014
• Distributor Facility Aware Date: 07/09/2014
• Event Location: Other
• Date Report to Manufacturer: 08/12/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2014
• 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