MAUDE Adverse Event Report: R. POON MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 66550

Device Problems Crack (1135); Split (2537)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the wheels are splitting open on it.

Manufacturer Narrative

The model number for the rollator involved in this event was obtained and found to be 66550.The manufacture for rollator 66550 is (b)(4).

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): R. POON; nanhai OH ; CH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3979980
• MDR Text Key: 4748626
• Report Number: 1525712-2014-04371
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/06/2014,07/03/2014

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: 08/06/2014
• Distributor Facility Aware Date: 07/03/2014
• Date Report to Manufacturer: 08/06/2014
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 08/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• 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