MAUDE Adverse Event Report: COMBRIDGE INTERNATIONAL COMPANY, LTD. ESSENTIAL ROLLATOR

Model Number ROL850ESR

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2017

Event Type  malfunction  

Event Description

Patient was sitting on this four wheeled walker when the front caster separated.There was no fall or injury.

• Brand Name: ESSENTIAL ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): COMBRIDGE INTERNATIONAL COMPANY, LTD.; unit 1, no. 66 yulong 3 road; dong sheng town; zhong shang city, 52841 4; CH 528414
• MDR Report Key: 7148095
• MDR Text Key: 96028122
• Report Number: 1056127-2017-00013
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131425
• UDI-Public: 754756131425
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/27/2017,12/11/2017

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: ROL850ESR
• Device Catalogue Number: W1700R-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2017
• Distributor Facility Aware Date: 12/11/2017
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 12/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109