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

Model Number 66550

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Dealer states the end user called in and reported that out of box, one brake was loose and would not engage, while the other side was so tight you could not move the handle to engage the brake.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4212383
• MDR Text Key: 5037894
• Report Number: 1531186-2014-05209
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/29/2014,10/09/2014

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: 66550
• 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: 10/29/2014
• Distributor Facility Aware Date: 10/09/2014
• Device Age: 22 MO
• Date Report to Manufacturer: 10/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other