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

Model Number 65851R

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  No Answer Provided  

Event Description

Customer alleges that seat cracked left of the hole to raise the seat to the edge and is beginning to crack on the right side of the hole to raise seat on a 65851r rollator.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4206460
• MDR Text Key: 5041554
• Report Number: 1531186-2014-05139
• 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: 10/28/2014,10/07/2014

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: 65851R
• 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: 10/28/2014
• Distributor Facility Aware Date: 10/07/2014
• Date Report to Manufacturer: 10/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68